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 HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THERE IS NO INCOMPLETE CONTINUOUS CURVILINEAR CAPSULORHEXIS AND HAD LINEAR TEARS APPEARED ALONG THE CAPSULE OCCURRED IN THE UNKNOWN EYE DURING REFRACTIVE SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY. THERE ARE MULTIPLE RELATED REPORTS FOR THIS EVENT. THIS REPORT ADDRESSES THE UNKNOWN PATIENT INITIAL'S, IN THE UNKNOWN EYE AND OTHER MANUFACTURER REPORTS WILL BE FILED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION PROVIDED IN H.3., H.6., AND H.11. A MANUFACTURING DEVICE HISTORY RECORD REVIEW WAS PERFORMED PRIOR TO PRODUCT RELEASE TO ENSURE THAT THE PRODUCT WAS MANUFACTURED IN COMPLIANCE WITH THE DEVICE MASTER RECORD. BASED ON THE ASSESSMENT, THE PRODUCT MET RELEASE CRITERIA. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT IS INCONCLUSIVE. SERVICE HISTORY WAS REVIEWED FOR THE SYSTEM. THERE WAS NO SERVICE RECORD (RELEVANT TO THE REPORTED EVENT), FOUND. ALL SURGICAL SYSTEMS ARE VERIFIED TO MEET SPECIFICATIONS AFTER INSTALLATION AND CUSTOMER-INITIATED SERVICE, IN ACCORDANCE WITH THE APPLICABLE PROCEDURE. A NUMBER OF CONTRIBUTING SURGICAL FACTORS (OR VARIABLES) CAN CONTRIBUTE TO THE REPORTED ¿INCOMPLETE CAPSULOTOMY¿ AND ¿POSTERIOR CAPSULAR TEAR.¿ BY PROACTIVELY IMPLEMENTING PREVENTIVE STRATEGIES TO OPTIMIZE SURGICAL OUTCOMES, SURGEONS WILL PRIORITIZE PATIENT SAFETY DURING CATARACT SURGERY PROCEDURES. HOWEVER, BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT REMAINS INCONCLUSIVE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).