WAVELIGHT FS200 FEMTOSECOND LASER

Additional Manufacturer Narrative

H.6: INVESTIGATION, INCLUDING ROOT CAUSE ANALYSIS, IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem

A PHYSICIAN REPORTED THAT PATIENT HAD EXPERIENCED DIFFUSE LAMELLAR KERATITIS IN THE RIGHT EYE AFTER REFRACTIVE SURGERY. PATIENT TREATED WITH TOPICAL STEROIDS. PATIENT IS DOING WELL. THE DIFFUSE LAMELLAR KERATITIS WAS CAUSED DUE TO ROOM CONTAMINATION NOT RELATED TO THE SYSTEM. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES FOR PATIENT¿S INITIALS SDG, RIGHT EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION PROVIDED IN D.9., H.3., H.6., AND H.11. A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED SERIAL NUMBER INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. A REVIEW OF THE TECHNICAL SERVICE ONSITE HISTORY SHOWED NO ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT. THE DEVICE WAS SUCCESSFULLY VERIFIED PRIOR THE DAY OF EVENT. MOST RECENT ONSITE VISIT FROM FIELD SERVICE ENGINEER PERFORMED AND SIGNED SERVICE INSTALLATION RECORD. SYSTEM MEETS SPECIFICATION AS PER SERVICE INSTALLATION RECORD. NO ON-SITE VISIT BY A FIELD SERVICE ENGINEER WAS IDENTIFIED IN RELATION TO THE REPORTED ISSUE. TYPICALLY, DIFFUSE LAMELLAR KERATITIS IS NOT DIRECTLY ATTRIBUTABLE TO THE DEVICE. CONTRIBUTING FACTORS OF DIFFUSE LAMELLAR KERATITIS COULD BE STERILIZATION OF INSTRUMENTS, ENVIRONMENT OF THE FACILITY, SURGICAL TECHNIQUES AS WELL AS PRE- AND POST-OPERATIVE MEDICATIONS. ACCORDING TO ATTACHED INFORMATION, THE ROOM CONDITIONS COULD BE A CONTRIBUTING FACTOR. THE ROOM AIR VENTS ARE DIRECTLY ABOVE THE PATIENT'S HEAD BLOWING DOWN AT THE HEAD OF THE LASER BED. THE SITE TESTS THE ROOM AND OTHER EXTERNAL FACTORS. STATEMENT FROM A SURGEON AT THE REPORTING CLINIC: "IT HAS BEEN AN ISSUE FOR THE LAST TWO YEARS ON AND OFF, AND THEY HAVE MADE CONSCIOUS EFFORTS TO ADDRESS STERILIZATION. NO FURTHER INVESTIGATION OF THE LOGFILES AND REVIEW OF THE TREATMENT REPORTS ARE NECESSARY. THE ROOT CAUSE COULD BE IDENTIFIED AND THE LOGFILES AND TREATMENT REPORTS FROM EARLIER REPORTED CASES FROM THIS CLUSTER WERE REVIEWED AND NO CONTRIBUTING FACTORS FOR DIFFUSE LAMELLAR KERATITIS COULD BE IDENTIFIED. NO PART IS EXPECTED TO BE RETURNED TO DEVICE FOR EVALUATION. THE ROOT CAUSE OF THE REPORTED ISSUE COULD BE DETERMINED AS EXTERNAL (FACILITY ENVIRONMENT RELATED) BASED ON A POORLY MAINTAINED AIR CONDITIONER SYSTEM. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).