Advanced Medical Optics (AMO)

Intralase FS Laser

Problems have occurred with the Intralase FS Lasers

Type in "Intralase" for the brand name to pull up MDRs filed on Intralase. The product code is GEX (you will get other reports not related to Intralase).

From the MDRs:

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THE INTRALASE FS LASER WAS USED TO CREATE A CORNEAL FLAP FOR BILATERAL MONOVISION LASIK SURGERY. THE FLAPS ON BOTH EYES WERE CREATED SUCCESSFULLY. AFTER THE FLAP WAS CREATED ON THE SECOND (LEFT) EYE, THE SUCTION WAS RELEASED AND THE SUCTION RING ASSEMBLY WAS REMOVED FROM THE EYE. THE BEAM DELIVERY DEVICE (BDD) WAS LIFTED OFF THE EYE WHILE THE SURGEON REPLACED THE CORNEAL FLAP. WHILE THE BDD WAS MOVING UPWARDS, DOWNWARD MOTION WAS INADVERTENTLY INITIATED. THE SURGEON AND ASSISTING SURGEON ATTEMPTED TO REVERSE DIRECTION OF THE BDD USING THE JOYSTICK, HOWEVER THE JOYSTICK BROKE OFF OF THE UNIT AS A RESULT OF EXCESSIVE FORCE. THE BDD DID NOT CONTACT THE EYE, BUT DID MAKE CONTACT WITH THE PT'S LEFT TEMPORAL PERIORBITAL AREA. THERE WAS NO VISIBLE OR DISCERNABLE INJURY TO THE PT, I.E., LESIONS OR CONTUSIONS; HOWEVER, AT THE 10-DAY POST-OPERATIVE VISIT, MILD YELLOWING IN THE AREA WAS NOTED BY THE SURGEON, INDICATING THAT BRUISING HAD OCCURRED. NO CONTACT WAS MADE WITH THE EYE, AND THE PT'S UNCORRECTED VISUAL ACUITY IMPROVED FROM 20/400 PRE-OPERATIVELY TO 20/70 ON THE FIRST DAY OF POST-OPERATIVE.

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THE JOYSTICK OF THE INTRALASE FS LASER WAS NOT WORKING PROPERLY. THE JOYSTICK, WHICH CONTROLS MOVEMENT OF THE DELIVERY SYSTEM, MOVED IN THE OPPOSITE DIRECTION. SPECIFICALLY, WHEN DOWNWARD MOVEMENT WAS REQUESTED, THE DELIVERY SYSTEM MOVED UP; AND WHEN UPWARD MOVEMENT WAS REQUESTED, THE DELIVERY SYSTEM MOVED DOWN. THIS MALFUNCTION WAS DETECTED PRIOR TO SURGERY, THERE WAS NO PATIENT INVOLVEMENT OR INJURY. UPWARD MOVEMENT DOES NOT POSE ANY PATIENT RISK, HOWEVER UNANTICIPATED DOWNWARD MOVEMENT OF THE DELIVERY SYSTEM HAS THE POTENTIAL TO CAUSE CORNEAL TRAUMA.

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DURING LASIK SURGERY IN 2002, THE INTRALASE FS LASER WAS USED TO CREATE THE CORNEAL FLAP AND THE INTRALASE FS DISPOSABLE PATIENT INTERFACE (PI) WAS USED TO APPLANATE THE CORNEA PRIOR TO FLAP CREATION. DURING FLAP CREATION, THERE WAS A SMALL AREA OF INEFFECTIVE PHOTODISRUPTION THAT REQUIRED ADDITIONAL MANIPULATION TO LIFT THE FLAP. THIS EVENT DID NOT RESULT IN ANY PATIENT INJURY AND THE PATIENT'S POST-OPERATIVE VISUAL ACUITY IS 20/20. AFTER REVIEWING A VIDEOTAPE OF THE SURGERY, THE SURGEON NOTICED THERE WAS A POSSIBLE DEFECT ON THE SURFACE OF THE PATIENT INTERFACE APPLANATION LENS. THE POSSIBLE LENS DEFECT WAS IN THE SAME LOCATION AS THE AREA OF INEFFECTIVE PHOTODISRUPTION. THIS EVENT IS BEING REPORTED AS A MALFUNCTION MDR BECAUSE IF IT RECURRED, IT COULD LEAD TO A CORNEAL TEAR AND POSSIBLE SURGICAL INTERVENTION.

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DURING LASIK SURGERY IN 2002, THE INTRALASE FS LASER WAS USED TO CREATE THE CORNEAL FLAP. DURING THE PROCEDURE, A SCREW HAD LOOSENED FROM THE DELIVERY SYSTEM AREA AND THE WASHER LANDED ON THE PATIENT'S FOREHEAD. THE PATIENT WAS NOT INJURED AND THE SURGERY CONTINUED WITHOUT INCIDENT. THIS EVENT IS BEING REPORTED AS A MALFUNCTION MDR BECAUSE IF IT RECURRED, IT COULD LEAD TO A CORNEAL ABRASION AND POSSIBLE SURGICAL INTERVENTION.

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ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION - REPORT DATE: 09/12/2003 MDR TEXT KEY: 1674969 Patient Sequence Number: 1

SUBSEQUENT TO LASIK SURGERY WITH THE INTRALASE FS LASER, THE PT'S VISUAL RECOVERY HAS BEEN DELAYED. THE SURGERY WAS UNEVENTFUL, HOWEVER, POSTOPERATIVELY, THE SURGEON OBSERVED WHAT HE DESCRIBED AS AN "ORANGE PEEL EFFECT" WITH DELAYED VISUAL RECOVERY. PREOPERATIVELY, THE PT'S BEST CORRECTED VISULA ACULTY (BCVA) WAS 20/20 IN BOTH EYES. AT THE 19-DAY POSTOPERATIVE VISIT, THE PT'S BCVA WAS 20/30 OD AND 20/60 OS. AT THE 2-MONTH POSTOPERATIVE VISIT, THE PT'S BCVA IMPROVED TO 20/25 OD. HOWEVER THE OS EYE WAS 20/50. THERE HAVE BEEN NO SECONDARY SURGICAL INTERVENTIONS PERFORMED AT THIS TIME.

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THE INTRALASE FS LASER WAS USED TO CREATE THE CORNEAL FLAPS FOR BILATERAL LASIK SURGERY IN 2003. A 120 MICRON FLAP WAS CREATED WITH THE INTRALASE FS LASER, HOWEVER WHEN THE SURGEON ATTEMPTED TO LIFT THE FLAP (IN THE OS EYE) WITH A SLADE SPATULA, HE CREATED A FALSE CHANNEL WITH THE SPATULA. THE SURGEON THEN INTRODUCED THE SPALULA FROM THE OPPOSITE SIDE AND THE FLAP LIFTED SUCCESSFULLY AND THE EXCIMER TREATMENT WAS PERFORMED. AT THE ONE DAY POSTOP VISIT, THE PATIENT PRESENTED WITH FLAP EDEMA, HAZO, RIDGES, AND BLURRY VISION. THE PATIENT WAS RETERRED TO A CORNEAL SPECIALIST FOR POSTOPERATIVE FOLLOW-UP. AT THE ONE-MONTH POSTOPERATIVE VISIT. THE PATIENT'S BEST CORRECTED VISUAL ACUITY (DCVA) IN THE AFFECTED (OS) EYE WAS 20/200, COMPARED WITH THE PATIENT'S PREOPERATIVE BCVA OF 20/20).

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SUBSEQUENT TO LASIK SURGERY WITH USE OF THE INTRALASE FS LASER TO CREATE THE CORNEAL FLAP, A PATIENT PRESENTED WITH DIFFUSE LAMELLAR KERATATIS (DLK) BILATERALLY. AT APPROXIMATELY ONE WEEK POSTOPERATIVELY, THE DLK HAD PROGRESSED TO STAFE IV AND CENTRAL FOLDS WERE OBSERVED. THE PATIENT WAS TREATED WITH TOPICAL STERIODS; HOWEVER THE FLAPS WERE NOT LITTED OR RINSED. AT THE 3 WEEK POSTOPERATIVE VISIT, THE PATIENT'S BEST CORRECTED VISUAL ACUITY HAD DECREASED MORE THAN 2 LINES AND RESULTED IN INDUCED ASTIGMATISM.

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ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION - REPORT DATE: 07/02/2003 MDR TEXT KEY: 1646970 Patient Sequence Number: 1

THE INTRALASE FS LASER AND INTRALASE PATIENT INTERFACE WERE USED TO CREATE THE CORNEAL FLAPS FOR BILATERIAL LASIK SURGEON. DURING SURGERY ON TEH OS EYE, THE DISSECTION WAS INCOMPLETE AND RESULTED IN A TORN CORNEAL FLAP. THE INCOMPLETE DISSECTION WAS LATER ATTRIBUTED TO A BENT PATIENT INTERFACE CONE. THE LASIK SURGERY WAS THEN PERFORMED SUCCESSFULLY AND THE PATIENT'S BEST CORRECTED VISUAL ACUITY (BCVA) IN THE AFFECTED EYE WAS 20/25 AT THE ONE WEEK POSTOPERATIVE VISIT. THE PATIENT'S PREOPERATIVE BCVA WAS 20/20. ALL THE TIME OF THE COMPLAINT CLOSURE, THE PATIENT'S BCVA IMPROVED TO 20/20 AT THE 3 MONTH POSTOPERATIVE VISIT. 6 MONTHS LATER INTRALASE WAS NOTIFIED THAT THIS PATIENT HAD LASIK ENHANCEMENT PERFORMED ON BOTH EYES, THE ENHANCEMENT PROCEDURE WAS NOT PERFORMED AS A RESULT OF THE COMPLICATION. DURING THE ENHANCEMENT ON THE OS EYE, A 160-MICRON FLAP WAS CREATED WITH THE INTRALASE FS LASER. THE SURGEON OBSERVED GAS BUBBLES FORMING UNDER THE PREVIOUS FLAP, SO HE WAITED 5 HOURS AND THEN CRCATED A SECOND FLAP AT A DEPTN TO 200 MICRONS. THE FLAP WAS LIFTED SUCCESSFULLY AND THE EXCIMER ABLATION WAS PERFORMED. AT THE PATIENT'S MOST RECENT POSTOPERATIVE VISIT, THE BCVA IN OS EYE HAD DECREASED FROM 20/20 PREOPERATIVELY TO 20/50 AND IRREGULAR ASTIGMATISM WAS OBSERVED. THE SURGEON IS CONSIDERING PERFORMING A CUSTOM EXCIMER TREATMENT.

ADDITIONAL MANUFACTURER NARRATIVE

REPORT DATE: 07/02/2003 MDR TEXT KEY: 1646973

THE INTRALASE PATIENT INTERFACE CONE WAS RETURNED TO INTRALASE FOR EVALUATION. THE RESULTS OF THE INVESTIGATION REVEALED THAT THE CONE DID NOT MEET SPECIFICATIONS. ONE OF THE FOUR CONE LEGS WAS SLIGHTLY BENT.

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"It was reported to intralase that subsequent to bilateral "bladeless" lasik, the pt developed severe "dlk," which was treated with long-term topical and oral steroids. Posterior subcapsular cataracts formed and intrastromal scarring resulted. Cataract surgery will be performed to prevent permanent impairment. It should be noted that the reporting physician assumed this pt's follow-up care and was not the surgeon who performed the lasix procedure."

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The intralase fs laser was used to create a corneal flap for lasik surgery in 2007 on patient's left (os) eye. The doctor reported he experienced a difficult flap lift, excessive opaque bubble layer (obl) and centration difficulties as patient had loose epithelium. A bandage contact lens (bcl) was placed due to an irregular corneal surface. The patient's preoperative best corrected visual acuity (bcva) was 20/20-2 os. Patient's postoperative bcva is 20/60 os. Current bcva has been requested from the facility, but information has not been provided as of 9/21/07. If additional information becomes available, a supplemental report will be submitted. The association between the event and the device is unknown.

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Manufacturer Narrative

An intralase clinical applications specialist (cas) has been in contact with the site obtaining patient follow-up status, as well as trying to identify a potential root cause for dlk. The cas visited the site in 2007 and performed an investigation. In summary, the probable root cause appears to be associated with the site not draining their sterilizer regularly. The cas advised site regarding sterilization practices and the site has since changed their statim 2000 sterilizer to a graham autoclave sterilizer. In addition, surgical instruments are now put in an ultrasonic cleaner, packaged, and then autoclaved. Dlk has resolved since noted changes were implemented.

Event Description

The intralase fs laser was used to create bilateral corneal flaps for lasik surgery in 2007. Postoperatively (eight days later) the patient was presented with central diffuse lamellar keratitis (dlk) in both eyes (ou). The right (od) eye with stage 2+ dlk and the left (os) with 4+ dlk and slight corneal melting. A flap lift and rinse was performed on left eye only. The patient was treated with steroids. The patient's preoperative best corrected visual acuity (bcva) was 20/20. Patient's postoperative bcva is 20/30 +0. 25+0. 25x115 os with mild haze and 20/20 od. The patient is responding to treatment and dlk has resolved. The association between the event and the device is unk.

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Event Description

The intralase fs laser was used to create bilateral corneal flaps for lasik surgery in 2007. One day postoperatively (the next day) the patient presented with diffuse lamellar keratosis (dlk) and central striae. The following month, the patient was diagnosed with central toxic keratopathy (ctk), slight central corneal melting on the left (os) eye and doctor opted to perform a flap lift and rinse on both (ou) eyes. The patient was prescribed with topical steroids and has responded to treatment. The patient's preoperative best corrected visual acuity (bcva) want 20/20 ou. Patient's postoperative bcva is 20/20 od and 20/25+2 os. Dlk and ctk have resolved. The association between the event and the device is unknown.

Manufacturer Narrative

An intralase clinical applications specialist (cas) provided surgery support in 2007, and has been in contact with the physician obtaining patient follow-up status, as well as trying to identify a potential root cause for dlk. The cas and physician believe that the cause of dlk is due to something in the surgical suite environment. The site has recently changed their air filter, started using a disposable canulas, and changed their cleaning solution for the instruments. After implementing these changes, the hospital has noticed a significant improvement in patient outcomes. An intralase field service engineer (fse) performed preventive maintenance on july 25, 2007 and the laser system met specifications and performed as intended.

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Manufacturer Narrative

On 07/2007, an intralase field service manager visited the site, provided surgery support and performed preventative maintenance. The laser system was assessed, and met all specifications and performed as intended. There were no issues observed during surgery support.

Event Description

The intralase fs laser was used to create bilateral corneal flaps lasik surgery in 2007. During surgery, the flap on the left eye (os) became decentered. Postoperatively, the pt presented with mild microstriae os and the following month, intervention was performed to lift, irrigate, and smooth the flap. The pt's preoperative best corrected visual acuity (bcva) was 20/20 in both eyes. Postoperatively, the pt's bcva is 20/16 in the left eye and 20/25 in the right eye. The association between the event and the device is unk.

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Manufacturer Narrative

In 2007, an intralase clinical application specialist (cas) visited the site and performed an investigation in attempt to determine a root cause. Cas inquired into instrument and surgical preparation practices, as well as technique. The cas did not identify any unusual practices, and found the laser system met specifications and performed as intended. One day later, an intralase field service engineer (fse) visited the site, performed minor alignment of the oscillator and found the laser system met specifications and performed as intended. A root cause has not been identified for the reported event.

Event Description

The intralase fs laser was used to create corneal bilateral flaps for lasik surgery in 2007. One week postoperatively, the pt presented with central toxic keratopathy (ctk), and stria at which time the doctor opted to perform stria removal and repositioned the flap. The pt's preoperative best corrected visual acuity (bcva) was 20/20 in the right (od) eye and 20/20 in the left (os) eye. The pt's current postoperative bcva is 20/30 od, 20/30 os and 20/25 in both (ou) eyes. The association between the event and the device is unknown.

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Manufacturer Narrative

On 05/04/2007, a field service engineer inspected the laser and performed a routine preventative maintenance. The laser system met specifications and performed as intended. Twenty seven days later, an intralase clinical applications specialist (cas) visited the site and modified the laser settings to doctor's preference. The laser met specifications and performed as intended upon departure. A root cause has not been identified for the reported event.

Event Description

The intralase fs laser was used to create bilateral corneal flaps for lasik surgery in 2007. One day postoperatively, the pt presented with trace diffuse lamellar keratitis (dlk) on the right (od) eye and stage 2+ on the left (os) eye. A flap lift and rinse was performed the following day on the left (os) eye only. Pt was treated with oral and topical steroids. The pt's preoperative best corrected visual acuity (bcva) was 20/20 both (ou) eyes. Postoperative bcva is 20/100 od and 20/15-2 os. The od eye was corrected for near vision and the bcva taken was distance vision (monovision treatment). The pt responded to treatment and dlk has resolved. The association between the event and the device is unknown.

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Manufacturer Narrative

Event Description

The intralase fs laser was used to create bilateral corneal flaps for lasik surgery in 2007. One day postoperatively, the pt presented with 2+ diffuse lamellar keratitis (dlk) in both (ou) eyes. A flap lift and rinse was performed four days later, and pt was treated with oral and topical steroids. The pt's preoperative best corrected visual acuity (bcva) in the right (od) eye was 20/20-1 and 20/25 in the left (os) eye. Postoperative bcva is 20/20 od and 20/50 os. The os eye was corrected for near vision and the bcva taken was for distance vision (monovision treatment). The pt responded to treatment and dlk has resolved. The association between the event and the device is unknown.

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Event Description

The intralase fs laser was used to create bilateral corneal flaps for lasik surgery in 2007, in both (ou) eyes. One day postoperatively (the followig day), the pt presented with diffuse lamellar keratitis (dlk) with central toxic keratopathy (ctk). The pt was treated with topical steroids. The preoperative best corrected visual acuity (bcva) was 20/20 ou. The pt's current postoperative bcva is 20/50 + od and bcva 20/30+os. Add'l info has been requested from the site, but none has been forthcoming. If add'l info is received, a supplemental medwatch shall be filed with fda. The physician does not believe the event is device related.

Manufacturer Narrative

An field svc engineer (fse) performed preventive maintenance on 04/19/07, and the laser sys performed as intended, and met specifications. On 05/08/07, an intralase clinical application specialist (cas) visited the site and performed an investigation in attempt to determine a root cause. Per cas, the surgeon believes the reported issue is related to something in the office and not the laser sys. Surgeon is seeking cas expertise to help identify a root cause. Cas made recommendations regarding potential contributors related to instrument preparation and sterilization practices. The cas did not identify any usual environmental or surgical technique issues.

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Event Description

The intralase fs laser was used to create a corneal flap for lasik surgery in 2007, in the left (os) eye. One day postoperatively (the next day), the pt presented with diffuse lamellar keratitis (dlk) with central toxic keratopathy (ctk). The pt was treated with topical steroids. The preoperative best corrected visual acuity (bcva) was 20/20. The pt's current postoperative bcva is 20/40. Add'l info has been requested from the site, but none has been forthcoming. If add'l info is received, a supplemental medwatch shall be filed with fda. The physician does not believe the event is device related.

Manufacturer Narrative

On 4/19/07, a field svc engineer (fse) performed preventive maintenance, and the laser maintenance performed as intended, and met specifications. On 5/08/07, an intralase clinical application specialist (cas) visited the site, and performed an investigation in attempt to determine a root cause. Per cas, the surgeon believes the reported issue is related to something in the office and not the laser sys. Surgeon is seeking cas expertise to help identify a root cause. Cas made recommendations regarding potential contributors related to instrument preparation and sterilization practices. The cas did not identify any unusual environmental or surgical technique issues.

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Event Description

The intralase fs laser was used to create bilateral corneal flaps for lasik surgery in 2007. One day postoperatively, the next day, the pt presented with stage 1+ diffuse lamellar keratitis (dlk) in both (ou) eyes. A flap lift and rinse was performed prior to that day. Pt was treated with topical steroids. The pt's preoperative best corrected visual acuity (bcva) was 20/20 ou. Postoperative uncorrected visual acuity (bcva) is 20/25 od and 20/25+2 os. The pt is responding to treatment and dlk has resolved. The association between the event and the device is unk.

Manufacturer Narrative

On 2/06/07, a field service engineer performed a scheduled preventative maintenance. The laser system met specifications and performed as intended. On 3/15/07, an intralase clinical applications specialist (cas) visited the site and noticed the laser settings are being modified on a continuous basis, against cas' advice. The site has had on-going construction adjacent to the surgical suite since 2006. An environmental company evaluated the surgical site 1/25/07 and noted the ventilation system was not working effectively, most likely due to an improperly installed air filter. Even though the site uses powder free gloves, white powder was observed on equipment and noted in the environmental report. On 3/29/07, an intralase director of clinical support found the laser system met specifications and performed as intended. It should be noted the organizations recommends treating stages 1 & 2 dlk with topical steroids and observation. The aao does not recommend performing a flap lift & rinse at these mild stages. Air filters haven't been changed as recommended by environmental company on 01/25/2007.

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Event Description

The intralase fs laser was used to create bilateral corneal flaps for lasik surgery in 2007. One day postoperatively, the patient presented with stage 2 diffuse lamellar keratitis (dlk) in both eyes (ou) and was prescribed topical and oral steriods. Two days later, the doctor performed a flap lift and rinse. Four days later, postoperative check up, the left eye (os) had progressed to stage 4 dlk. The following month, postoperative check up, dlk was resolved but central scarring present. The patient's preoperative best corrected visual acuity (bcva) was 20/16 ou. Postoperative bcva as of the same day, in the right (od) was 20/16 and 20/125 os. The patient is responding to treatment and dlk has resolved. The association between the event and the device is unknown.

Manufacturer Narrative

In 2007, an intralase field service engineer (fse) visited the site and performed scheduled preventative maintenance-no adjustments were required. Thirteen days later, an fse returned to site due to dlk report and calibarated z-baseline offset and found the system met specifications and performed as intended upon departure. An intralase clinical applications specialist (cas)has been in contact with the site obtaining patient follow up status and trying to identify a possible root cause. Although a single root cause was no identified, the site made the following changes: introduced use of head coverings for staff, disposable covers for buttons on system which are changed after every procedure, use of different cannulae, speculums, modified energy by 0. 05uj lower and cleaned the humidifier and ventilation system. Since implementation of changes noted above, the site has seen a reduction in dlk cases.

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Event Description

The intralase fs laser was used to create a corneal flap for lasik surgery in 2007 in the left (os) eye. One day postoperatively, the patient presented with stage 2 diffuse lamellar keratitis (dlk). The patient was prescribed topical and oral steroids. Two days later, the doctor performed a flap lift and rinse. The patient's preoperative best corrected visual acuity (bcva) was 20/12. 5 both (ou) eyes. Postoperative bcva as of the following month was 20/12. 5 ou. The patient is responding to treatment and dlk has resolved. The association between the event and the device is unk.

Manufacturer Narrative

On 3/06/07 an intralase field service engineer (fse) visited the site and performed scheduled preventative maintenance - no adjustments were required. The following month, an fse returned to site due to dlk report and calibrated z-baseline offset and found the system met specifications and performed as intended upon departure. An intralase clinical applications specialist (cas) has been in contact with the site obtaining patient follow up status and trying to identify a possible root cause. Although a single root cause was not identified, the site made the following changes: introduced use of head coverings for staff, disposable covers for buttons on system which are changed after every procedure, use of different cannulae, speculums, modified energy by 0. 05uj lower and cleaned the humidifier and ventilation system. Since implementation of changes noted above, the site has seen a reduction in dlk cases.

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Event Description

The inralase fs laser was used to create bilateral corneal flaps for lasik surgery in 2007. One day postoperatively (the following day) the pt presented with stage 2 diffuse lamellar keratitis (dlk) in both eyes (ou). A flap lift and rinse was performed ou four days later. Pt was treated with topical steroids. The pt's preoperative best corrected visual acuity (bcva) was 20/20 ou. Postoperative bcva is 20/25 od and 20/20 os. The pt responded to treatment and dlk has resolved. The association between the event and the device is unk.

Manufacturer Narrative

In 2007, a field service engineer inspected the laser. The laser sys met specs and performed as intended. Five days later, an intralase clinical applications specialist (cas) provided surgery support and observed mold inside the sterilizer. Cas recommended replacement with new sterilizer and site followed recommendation. Additionally, cas modified laser settings. It should be noted that the american academy of ophthalmology (aao) recommends treating stages 1 & 2 dkl with topical steroids and observation. The aao does not recommend performing a flap lift & rinse at these mild stages. The physician did not follow the recommended treatment protocol.

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Event Description

The intralase fs laser was used to create bilateral corneal flaps for lasik surgery in 2007. One day postoperatively, the patient presented with grade 2 diffuse lamellar keratitis (dlk) in both eyes (ou). A flap lift and rinse was performed ou on the same day. Dlk seemed to progress to grade 3-4+ in the right (od) eye and grade 3+ dlk in the left (os) eye so a second lift and rinse was performed ou three days later, and a third lift and rinse was performed ou the following day. Central cornea of od began melting on the same day. Patient was treated with oral and topical steroids and a bandage contact lens was placed after the first lift and rinse. The patient's preoperative best corrected visual acuity (bcva) was 20/20 ou. Postoperative uncorrected visual acuity (ucva) is 20/50 od and 20/20 os. The patient's next follow up visit is scheduled for approx one and a half month later. Additional information will be supplied to fda when received. The association between the event and the device is unknown.

Manufacturer Narrative

On 02/06/07, a field service engineer inspected the laser and performed a scheduled preventative maintenance. The laser system met specifications and performed as intended. The following month, an intralase clinical applications specialist (cas) provided surgery support and observed the site has been modifying their laser settings on a continuous basis, against the advice of the cas. Additionally, the site has had on-going construction adjacent to the surgical suite since 2006 that is stirring up dust and debris in the area. An environmental company evaluated the surgical site and noted that the ventilation system was not working effectively, most likely due to an air filter that was improperly installed. White powder was observed on equipment and noted in the environmental report, even though the site uses powder free gloves.

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The intralase fs laser was used to create bilateral corneal flaps for lasik surgery in 2007. One week post-op (approximately a week later), patient was noted to have elevated intraocular pressure (iop) in the right (od) eye due to pigmentary glaucoma. The patient's preoperative best corrected visual acuity (bcva) was 20/15 od. Postoperatively, the patient's bcva is 20/40 od. Patient treated with medications to address the increased iop. Updated patient status was requested, but information has not been provided to filutowski eye institute by co-managed office as of approx two months later. However, if additional information becomes available, supplemental report will be submitted to fda. The association between the event and the device is unknown.

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Femtosecond lasers offer patients no substantial advantage over the improved results obtained with new generation microkeratomes for safety and precision, according to Theo Seiler MD, IROC, Zürich, Switzerland, who described the disadvantages of femtosecond lasers as the advocatus diaboli in this discussion. Actually the femtosecond laser is medically indicated in a minority of our patients, probably less than five per cent. Seducing patients to get femtosecond LASIK as a standard procedure is at least an overkill, if not unethical, according to some, he said. Recent studies seem to concur.A 100-patient investigation by Lim in 2006 showed that the femtosecond laser had failed to have significant superiority in clinical outcomes like contrast sensitivity and low contrast visual acuity, while in 2007, Patel revealed in over 100 patients that the method of flap creation did not affect the visual outcome. Although flap thickness regularity is one of the main reasons surgeons choose femtosecond laser, an investigation by Talamo revealed that femtosecond-laser flaps were an average of 119± 12μm while mechanical microkeratome flaps measured 130±19μm on average, which reduces variance only slightly, Dr Seiler said.

Rare rainbow glare side effect still occurs with latest IntraLase laser

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CHICAGO Use of the latest IntraLase femtosecond laser does not diminish the occurrence of a rare side effect called rainbow glare, according to a physician who has studied the phenomenon.

"Rainbow glare is caused from the perfectly regular grading pattern of the IntraLASIK pulses in the interface that sets up the constructive interference that splits white light into its component colors and into a number of different bands," Ronald R. Krueger, MD, explained in an interview with Ocular Surgery News after his presentation at the American Society of Cataract and Refractive Surgery meeting, here.

Twenty of the 278 patients in the study reported experiencing the mild optical side effect, and most of these patients reported seeing six bands of light. All of these patients had IntraLASIK using a 60 KHz IntraLase femtosecond laser (Advanced Medical Optics).

There does not appear to be an association with refraction, age or gender, Dr. Krueger noted.

Dr. Krueger said he hopes the phenomenon will be eradicated with future femtosecond technologies.

"Newer femtosecond lasers with smaller energies and tighter spacing like the Ziemer laser may not show this phenomenon, and that's a point of future investigation, to see if scattering effects might be different with different femtosecond lasers," he said.

Advanced Medical Optics Voluntarily Recalls Complete MoisturePlus Contact Lens Solution

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The U.S. Food and Drug Administration is alerting health care professionals and their patients who wear soft contact lenses about a voluntary recall of Complete MoisturePlus Multi Purpose Solution manufactured by Advanced Medical Optics of Santa Ana, Ca.

The company is taking this action as a precaution because of reports of a rare, but serious, eye infection, Acanthamoeba keratitis, caused by a parasite. The link between the solution and the infection was identified as a result of an investigation by the Centers for Disease Control and Prevention (CDC).

Consumers who wear soft contact lenses should stop using the solution, discard all partially-used or unopened bottles and replace their lenses and storage container.

"We believe the company acted responsibly in taking this voluntary action and support their decision to be proactive in the interest of public health," said Daniel Schultz, M.D., director of FDA's Center for Devices and Radiological Health. "FDA and CDC are working closely with the company to collect additional information and we will continue to alert consumers and advise them as more information becomes available."

Acanthamoeba keratitis may lead to vision loss with some patients requiring a corneal transplant. The infection primarily affects otherwise healthy people who wear contact lenses.

Consumers should ask their doctor about choosing an appropriate alternative cleaning/disinfecting product and seek immediate treatment if they have symptoms of eye infection as early diagnosis is important for effective treatment. The symptoms of Acanthamoeba keratitis can be very similar to those of other more common eye infections and may include eye pain or redness, blurred vision, light sensitivity, sensation of something in the eye or excessive tearing but Acanthamoeba is more difficult to treat.

It is estimated that Acanthamoeba keratitis infections occur in approximately 2 out of every 1 million contact lens users in the United States each year. However, in a multi-state investigation to evaluate a recent increase in Acanthamoeba keratitis cases, CDC determined that the risk of developing AK was at least seven times greater for those consumers who used Complete MoisturePlus solution versus those who did not. Additional information regarding the CDC results is available at the CDC website http://www.cdc.gov/mmwr/preview/mmwrhtml/mm56d526a1.htm.

"The ongoing CDC investigation is a collaborative effort," said Michael Beach, M.D., a Division of Parasitic Diseases team leader with CDC. "We are working with FDA, state, territory, university, and clinical partners in an effort to further understand whether usage or contamination of this solution led to these Acanthamoeba infections."

All contact lens users should closely adhere to the following measures to help prevent eye infections:

Remove contact lenses before any activity involving contact with water, including showering, using a hot tub, or swimming.
Wash hands with soap and water and dry them before handling contact lenses.
Clean contact lenses according to manufacturer guidelines and instructions from an eye care professional.
- Use fresh cleaning or disinfecting solution each time lenses are cleaned and stored. Never reuse or top off old solution.
- Never use saline solution and rewetting drops to disinfect lenses. Neither solution is an effective or approved disinfectant.
Schedule regular eye exams with your eye care professional
Wear and replace contact lenses according to the schedule prescribed by your eye care professional.
Store lenses in a proper storage case.
- Storage cases should be irrigated with sterile contact lens solution (never use tap water) and left open to dry after each use.
- Replace storage cases at least once every three months.

FDA and CDC want to gather information related to Acanthamoeba keratitis in contact lens users. Report adverse events related to these products to MedWatch, the FDA's voluntary reporting program: www.fda.gov/medwatch/report.htm; Phone: (800) 332-1088; Fax: (800) 332-0178; Mail: MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20852-9787.

Consumers who believe they are in possession of the recalled product may call the company at 1-888-899-9183.

Additional information about Acanthamoeba infection is available from the CDC website at http://www.cdc.gov/ncidod/dpd/parasites/acanthamoeba/index.htm.

Medical Device Recalls Class 2 Recall COMPLETE MoisturePLUS & COMPLETE Amino Moist

SOURCE

Date Recall Initiated: September 15, 2006

Date Posted: March 01, 2007

Recall Number: Z-0344-2007

Product: COMPLETE MoisturePLUS Multi-Purpose Solution (US and Asia Pacific markets, excluding Japan) & COMPLETE Amino Moist Multi-Purpose Solution (Japan only)

Code Information: US Product Number 93184, Lot Numbers: ZB03087, ZB03724, ZB03734, ZB03735, ZB03736 & ZB03739 US Product Number 90104US, Lot Numbers: ZB02710, ZB02714, ZB02718 & ZB02722 US Product Number 90105US, Lot Numbers: ZB02746, ZB02750, ZB02771, ZB02792, ZB02796, ZB02800, ZB02704 & ZB03535

Recalling Firm/Manufacturer: Advanced Medical Optics, Inc. 1700 E Saint Andrew Pl Santa Ana , California 92705-4933 For Addition Information Contact Sandra F. Selvaggi 714-247-8656

Reason For Recall: Due to a potential sterility issue with the product container. Three lots sold in Japan were found to have bacterial contamination, which compromised sterility. Because of this production-line issue at the firm's plant in China, AMO is recalling lots that were manufactured on the same production lines during the same production period.

Action: Beginning on September 15, 2006, a product notification letter was sent via facsimile or communicated via telephone with each of the customer accounts. Beginning on September 19, 2006, an AMO Japan sales representative visited each of the customer accounts obtaining COMPLETE Amino Moist Multi-Purpose Solution subject to recall. Letters dated November 21, 2006 were sent from AMO, Santa Ana, California beginning Novemer 27, 2006. Firm Initiated recall is ongoing.

Quantity in Commerce: 182,678 units for all US products, 2,943,207 units worldwide

Distribution: Worldwide including USA, Australia, China, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, New Zealand, Philippines, Singapore, Sri Lanka, Taiwan and Thailand.

Medical Device Recalls Class 2 Recall Krystal Klear Rinse

SOURCE

Date Recall Initiated: September 15, 2006

Date Posted: March 01, 2007

Recall Number: Z-0345-2007

Product: Krystal Klear Rinse (China only)

Code Information: No US distribution

Recalling Firm/Manufacturer: Advanced Medical Optics, Inc. 1700 E Saint Andrew Pl Santa Ana , California 92705-4933 For Addition Information Contact Sandra F. Selvaggi 714-247-8656

Quantity in Commerce: 182,678 units for all US products, 2,943,207 units worldwide

Distribution Worldwide including USA, Australia, China, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, New Zealand, Philippines, Singapore, Sri Lanka, Taiwan and Thailand.

Medical Device Recalls Class 2 Recall COMPLETE Multi-Purpose, 10 Minute, Comfort 8 in 1, Comfort Plus, and Protec

SOURCE

Date Recall Initiated: September 15, 2006

Date Posted: March 01, 2007

Recall Number: Z-0346-2007

Product: COMPLETE Multi-Purpose Solution (Asia Pacific markets, excluding Japan, Korea and Thailand), COMPLETE 10 Minute (Japan only), Comfort 8 in 1 Solution (Indonesia only), COMPLETE Comfort Plus All in One Solution (Korea only) & COMPLETE Protec Formula Multi-Purpose Solution (Thailand only)

Code Information: No US distribution

Recalling Firm/Manufacturer: Advanced Medical Optics, Inc 1700 E Saint Andrew Pl Santa Ana , California 92705-4933 For Addition Information Contact Sandra F. Selvaggi 714-247-8656

Reason For Recall: Due to a potential sterility issue with the product container. Three lots sold in Japan were found to have bacterial contamination, which compromised sterility. Because of this production-line issue at the firm''s plant in China, AMO is recalling lots that were manufactured on the same production lines during the same production period.

Quantity in Commerce: 182,678 units for all US products, 2,943,207 units worldwide

Distribution Worldwide including USA, Australia, China, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, New Zealand, Philippines, Singapore, Sri Lanka, Taiwan and Thailand.

Medical Device Recalls Class 2 Recall Complete Blink N Clean

SOURCE

Date Recall Initiated: September 15, 2006

Date Posted: March 01, 2007

Recall Number: Z-0347-2007

Product: Complete Blink N Clean (US and Asia Pacific markets)

Code Information: Lot numbers: ZB02845, ZB03506 & ZB03510 for US

Recalling Firm/Manufacturer: Advanced Medical Optics, Inc. 1700 E Saint Andrew Pl Santa Ana , California 92705-4933 For Addition Information Contact Sandra F. Selvaggi 714-247-8656

Reason For Recall: Due to a potential sterility issue with the product container. Three lots sold in Japan were found to have bacterial contamination, which compromised sterility. Because of this production-line issue at the firm''s plant in China, AMO is recalling lots that were manufactured on the same production lines during the same production period.

Quantity in Commerce: 182,678 units for all US products, 2,943,207 units worldwide

Distribution Worldwide including USA, Australia, China, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, New Zealand, Philippines, Singapore, Sri Lanka, Taiwan and Thailand.

Medical Device Recalls Class 2 Recall Lens Plus Ocupure

SOURCE

Date Recall Initiated: September 15, 2006

Date Posted: March 01, 2007

Recall Number: Z-0348-2007

Product: Lens Plus Ocupure Saline Sterile Rinsing Solution (Asia Pacific markets, excluding Japan) & Consept Rinsing Solution (Japan only)

Code Information: No US distribution

Recalling Firm/Manufacturer: Advanced Medical Optics, Inc. 1700 E Saint Andrew Pl Santa Ana , California 92705-4933 For Addition Information Contact Sandra F. Selvaggi 714-247-8656

Reason For Recall: Due to a potential sterility issue with the product container. Three lots sold in Japan were found to have bacterial contamination, which compromised sterility. Because of this production-line issue at the firm''s plant in China, AMO is recalling lots that were manufactured on the same production lines during the same production period.

Quantity in Commerce: 182,678 units for all US products, 2,943,207 units worldwide

Distribution Worldwide including USA, Australia, China, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, New Zealand, Philippines, Singapore, Sri Lanka, Taiwan and Thailand.

Spherical aberrations persist after LASIK with laser or microkeratome created flaps

SOURCE

OSN SuperSite Top Story 5/10/2007

FORT LAUDERDALE, Fla. — Spherical aberration increases and remains elevated for at least 1 year after LASIK regardless of whether flaps are created using a femtosecond laser or a mechanical microkeratome, according to a study presented here.

However, the study data show that the femtosecond laser induced lasting spherical aberration similar to that resulting from microkeratomes, he said.

Femtosecond laser should not be standard of care, surgeon says

SOURCE

OSN SuperSite Top Story 5/22/2007

"Seducing patients to get femtosecond LASIK as the standard is overkill," Theo Seiler, MD, PhD, said in a counterargument after Thomas Neuhann, MD, offered a stance in favor of femtosecond lasers.

According to Dr. Seiler, recent papers published in peer-reviewed journals have concluded that flap creation does not affect visual outcomes. He also said that the frequency of transient light sensitivity, although improved, is still a drawback.

A Comparative Confocal Microscopy Analysis After LASIK With the IntraLase Femtosecond Laser vs Hansatome Microkeratome

Journal of Refractive Surgery Vol. 23 No. 3 March 2007

Manuel Ramírez, MD; Everardo Hernández-Quintela, MD, MSc; Ramón Naranjo-Tackman, MD

In our study, we observed the same absence of a subepithelial nerve plexus at 1 week and 1 month postoperatively in the eyes operated with the femtosecond laser system. The detection of bright, reflective particles at the interface by confocal microscopy after LASIK has been consistently described in human corneas in previous studies. 6,7 Several theories explain the presence of these reflective particles at the interface. Kaufman et al8 attributed the refl ective particles to surface debris on the microkeratome blades, probably caused by sterile wax or oil-like material, whereas Hirst and Vandeleur9 attributed them to exposure of the methylcellulose sponges to the excimer laser beam during the stromal ablation. This issue has yet to be resolved. Dawson et al10 studied these interface refl ective particles after LASIK and made a pathologic correlation, suggesting that the corneal interface wound over the center of the cornea consists of a hypocellular primitive stromal scar, which contains cellular structures that appear on confocal microscopy as interface refl ective particles, such as intracytoplasmic vacuoles at the activated keratocytes, implanted and degenerated epithelial cells, and fragmented fibrillar collagen. In the present study, no significant difference was found in the number of interface refl ective particles in tissue treated with the femtosecond laser and that treated with the mechanical microkeratome at 1 week and 1 month postoperatively. This finding is consistent with that of Dawson et al,10 and the same types of refl ective particles were found using both systems. Behind the interface at the ablation zone, the keratocytes appeared as hyper-reflective objects with visible cytoplasm processes, which are the same characteristics that have been described as activated keratocytes in previous reports.6,7 We found no signifi cant difference in the morphological findings by confocal microscopy at the fl ap interface after LASIK in eyes treated with the femtosecond laser and a mechanical microkeratome.

Central Flap Necrosis After LASIK With Microkeratome and Femtosecond Laser Created Flaps

Journal of Refractive Surgery Vol. 23 No. 3 March 2007

Bryan C. Hainline, MD; Marianne O. Price, PhD; David M. Choi, MD; Francis W. Price Jr, MD

#1

A 45-year-old man underwent uncomplicated LASIK with the VISX Star S4 and IntraLase lasers for 5.75 D sphere in the right eye. Preoperative BSCVA was 20/15...

...On postoperative day 4, the patient had no complaints and examination of the flap showed central infl ammation of the entire flap thickness with moderate sands in the bed, no epithelial defect, and a cracked-glass pattern in the central fl ap (Fig 1). A flap lift was performed and some minimal inflammatory debris was observed in the interface with a jelly-like consistency in the central portion of the flap. By postoperative day 6, necrosis of flap tissue had occurred, causing wrinkling and depression of the central fl ap (Fig 2). The patient continued on prednisolone acetate 1% four times daily for 2 weeks with a subsequent 3-week taper. Seven weeks after surgery, UCVA in the right eye was 20/301 and manifest refraction did not improve. The flap at this time showed central haze and scarring.

#2

A 47-year-old woman underwent uncomplicated LASIK with a VISX Star 4 and IntraLase lasers for refraction of 3.00 0.50 75 in the right eye and 3.00 1.00 170 in the left eye. Preoperative BSCVA was 20/20 in each eye. On postoperative day 1, the patient complained of foreign body sensation in both eyes but no pain...

...Slit-lamp examination showed mild interface inflammation and oil in the interface superiorly in the right eye and central flap haze with mild to moderate inflammation in the peripheral interface in the left eye. A flap lift was performed in the left eye and minimal inflammatory debris was observed on the anterior stroma with a jelly-like consistency in the central portion of the flap. On postoperative day 14, the flap was clear in the right eye and the fl ap in the left eye showed mild central haze with folds and central depression but no interface inflammation.

A Lighter Defter Touch

SOURCE

By Michelle Andrews

Excerpt:

Andrew Jankovich had the Cadillac of LASIK eye procedures. His Cincinnati surgeon used the IntraLase laser to cut the flap and wavefront technology to guide the laser that reshaped his corneas. Following the surgery, his vision was 20/15, and his doctor said everything looked fine. But almost immediately, he noticed that his left eye was scratchy and irritated. Instead of going away, the problem worsened, and he now has severe dry eye. It's been a year now, and he says he constantly feels as if there's a hair in his eye or a raw spot there. Special eyedrops make it slightly better, but it never goes away. If he could make the choice again, Jankovich says, "I'd wear 3-inch-thick glasses instead."

For many people, ditching their glasses is a big part of the appeal of laser eye surgery. But before you pony up thousands of dollars, make sure you understand the potential risks and limitations. Only then can you make a clear-eyed choice.

SOURCE

IntraLase: Changing the LASIK Landscape

Though the exact cause of TLS is still uncertain, some surgeons believe that the inflammation is caused by necrotic cellular debris…

Transient light sensitivity a minor complication of IntraLase use

Some users of the IntraLase femtosecond laser keratome first noticed the complication when they began working with the system more than 2 years ago. Since then, the phenomenon has gone under multiple names.

Flap folds after femtosecond LASIK

To report a case of bilateral flap folds after a laser-assisted in situ keratomileusis (LASIK) procedure in which the flap was created by the femtosecond laser.

Macular hemorrhage after laser in situ keratomileusis (LASIK) with femtosecond laser flap creation

To report the first case of macular hemorrhage following LASIK with femtosecond laser flap creation.

Refractive surgery: lessons to be learned

"Indeed the long-term problems created by laser refractive surgery are not yet a major issue, but soon will be."

Complications of refractive excimer laser surgery

A German article related to complications.

VISX - Possible Deception?

VISX reported that 97.7% (84/86) of eyes had UCVA of 20/20 or better at 12 months. These 86 eyes represent only 24.5% of patients. Accountability is reported to be 95.6%, despite the fact that 70.7% (248/351) of patients were labeled “not yet eligible” for analysis at 12 months.