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 SHE OBSERVED A BRIEF PUFF AT THE TIME OF CAPSULOTOMY VISUALIZATION OF THE ANTERIOR CAPSULE WAS SEVERELY LIMITED DUE TO THE DENSITY OF THE MATURE CATARACT AND TRYPAN BLUE WAS NOT APPLIED, ONCE THE CAPSULOTOMY WAS COMPLETED A SMALL ANTERIOR CAPSULAR TEAR WAS SUBSEQUENTLY IDENTIFIED BENEATH THE PRIMARY INCISION IN LEFT EYE OF THE PATIENT DURING REFRACTIVE SURGERY.