LENSX LASER SYSTEM

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. ALCON LENSX (SITE #3008772169) IS NO LONGER OPERATIONAL. LENSX MANUFACTURED PRODUCTS ARE MAINTAINED AND INVESTIGATED BY THE ALCON RESEARCH, LTD. IRVINE TECHNOLOGY CENTER SITE #2028159). THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Description of Event or Problem

A PHYSICIAN REPORTED THAT THERE WAS A SIGNIFICANT DISCREPANCY BETWEEN THE PLANNED FLAP THICKNESS (ONE HUNDRED TWENTY MICRONS) AND THE MEASURED FLAP THICKNESS (ONE HUNDRED SEVENTY MICRONS) INTRAOPERATIVELY ON THE LASER USING THE PACHYMETRY FUNCTION RESULTED IN THICK FLAP IN THE LEFT EYE OF A PATIENT DURING REFRACTIVE SURGERY. CUSTOMER PERFORMED THE ADDITIONAL EXAMINATIONS, INCLUDING OPTICAL COHERENCE TOMOGRAPHY MEASUREMENTS CONDUCTED THREE DAYS POSTOPERATIVELY, AND CONFIRMED THAT FLAP THICKNESS SIGNIFICANTLY DIFFERED FROM THE PLANNED VALUES. THERE IS NO UNPLANNED MEDICAL OR SURGICAL INTERVENTION AT THE TIME OF EVENT. THERE ARE MULTIPLE RELATED REPORTS FOR THIS FACILITY. THIS REPORT ADDRESSES THE PATIENT ONE, IN THE LEFT EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.