WAVELIGHT FS200 FEMTOSECOND LASER

Additional Manufacturer Narrative

H.3., 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 NON-HEALTHCARE PROFESSIONAL REPORTED THAT PATIENT HAD EXPERIENCED DIFFUSE LAMELLAR KERATITIS IN THE LEFT EYE AFTER REFRACTIVE SURGERY. THE DIFFUSE LAMELLAR KERATITIS WAS CAUSED DUE TO TOO MUCH CLEANING CHEMICALS PREVIOUSLY AND THE ROOM IS NOT WELL VENTILATED; PATIENTS ARE DOING VISUALLY GOOD. THE SITE ORDERED A NEW STERILIZER AS WELL AS NEW INSTRUMENTS. FILED SERVICE ENGINEER WENT TO THE SITE AND CHECKED THE SYSTEM AND IT IS WORKING CORRECTLY. THE SITE HAS AN AIR PURIFIER IN THE ROOM BUT STATED THEY HAVE NOT CHANGED THE FILTER IN A VERY LONG TIME; THEY STATED NOTHING HAS CHANGED IN THEIR STERILIZATION PROCESS. THEY ARE CONTINUING TO FOLLOW UP WITH PATIENTS. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES THE PATIENT UNKNOWN, UNKNOWN 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: SYSTEM WAS SUCCESSFULLY VERIFIED AFTER THE SURGERY DATE. MOST RECENT ONSITE VISIT FROM FIELD SERVICE ENGINEER PERFORMED AND SIGNED SERVICE INSTALLATION RECORD. THE DEVICE MEETS SPECIFICATIONS AS PER SERVICE INSTALLATION RECORD. NO TREATMENT INFORMATION WERE PROVIDED INCLUDING DAY OF EVENT. AS THE DAY OF TREATMENT IS NOT KNOWN NO LOGFILE REVIEW CAN BE PERFORMED. DURING PREVIOUS CASES OF DIFFUSE LAMELLAR KERATITIS AND CENTRAL TOXIC KERATOPATHY NO DEVICE MALFUNCTION COULD BE IDENTIFIED WITHIN THE LOGFILES, AND THE SYSTEM WAS WORKING WITHIN SPECIFICATIONS FOR ALL TREATMENTS. NO COMPLAINT-RELATED PRODUCT IS EXPECTED TO BE RETURNED FOR INVESTIGATION. NOT ENOUGH INFORMATION WAS PROVIDED TO PROPERLY COMPLETE AN INVESTIGATION. THEREFORE, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE IDENTIFIED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).