LENSX LASER SYSTEM

Description of Event or Problem

A NON HEALTHCARE PROFESSIONAL REPORTED THAT PHYSICIAN FOUND DIFFICULTY IN LIFTING THE FLAP IN THE UNKNOWN EYE OF THE PATIENT DURING REFRACTIVE SURGERY. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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. BASED ON THE ASSESSMENT, THE PRODUCT MET RELEASE CRITERIA. THE COMPANY REPRESENTATIVE WAS UNABLE TO CONFIRM NOR REPLICATE THE REPORTED ISSUE. THE SYSTEM WAS TESTED AND FOUND TO MEET PRODUCT SPECIFICATIONS. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT IS INCONCLUSIVE. BASED ON THE INFORMATION OBTAINED, THE ROOT CAUSE OF THE REPORTED EVENT IS INCONCLUSIVE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).