LENSX LASER SYSTEM

Description of Event or Problem

A PHYSICIAN REPORTED THAT SYSTEM NOT EMITTING LASER AND FLAP BECAME FIRM AS A RESULT FLAP COULD NOT BE CUT PROPERLY IN THE LEFT EYE OF THE PATIENT DURING REFRACTIVE SURGERY, ADDITIONALLY POSTOPERATIVE VISUAL OUTCOME NOT REACHING THE EXPECTED LEVEL. PATIENT REPORTED VISUAL DISTURBANCE WHICH PERSISTED. THE SYMPTOMS ARE CONTINUING.

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).

Additional Manufacturer Narrative

A MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED PRIOR TO PRODUCT RELEASE TO ENSURE THAT THE PRODUCT WAS MANUFACTURED IN COMPLIANCE WITH THE DEVICE MASTER RECORD. SERVICE HISTORY WAS REVIEWED FOR THE SYSTEM. THERE WAS NO SERVICE RECORD (RELEVANT TO THE REPORTED EVENT), FOUND. HOWEVER, THE SYSTEM WAS LAST SERVICED PRIOR TO THE REPORTED EVENT PER SERVICE RECORD (SR). A NUMBER OF CONTRIBUTING SURGICAL FACTORS (OR VARIABLES) CAN CONTRIBUTE TO THE REPORTED ISSUES. BY PROACTIVELY IMPLEMENTING PREVENTIVE STRATEGIES TO OPTIMIZE SURGICAL OUTCOMES, SURGEONS WILL PRIORITIZE PATIENT SAFETY DURING SURGICAL PROCEDURES. HOWEVER, BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT REMAINS INCONCLUSIVE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).