LIQUID OPTICS INTERFACE

Additional Manufacturer Narrative

DEVICE EVALUATION: TEN (10) INVESTIGATIONS WERE COMPLETED DURING THE PERIOD. THERE WERE TWO (2) DEVICES RETURNED. VISUAL INSPECTIONS DID NOT REVEAL ANY OBVIOUS DEFECTS OR DAMAGES. FUNCTIONALITY TEST WERE PERFORMED, AND THE RESULTS WERE FOUND WITHIN SPECIFICATIONS. THE REPORTED EVENT WAS NOT CONFIRMED. A REVIEW OF THE RECORDS RELATED TO THE DEVICES THAT INCLUDED LABELING AND TRENDING SHOWED THAT THE DEVICES AND ITS COMPONENTS ALL MET SPECIFICATIONS PRIOR TO BEING RELEASED. NO PRODUCT DEFICIENCY WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

Additional Manufacturer Narrative

H10 -LIST OF ALL LOT NUMBERS OF THE DEVICES AND QUANTITY: 24084555 (X3), 25012555 (X2), 25393193 (X1), 60645679 (X1), 60662471 (X2), 60662472(X1), UNKNOWN (X2). DEVICE EVALUATION: TWO (2) INVESTIGATIONS WERE COMPLETED DURING THE PERIOD. PRODUCTS WERE NOT RETURNED. A REVIEW OF THE RECORDS RELATED TO THE DEVICES THAT INCLUDED LABELING, MANUALS, TRENDING, AND DEVICE HISTORY RECORD (DHR) SHOWED THAT THE DEVICES AND ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. NO PRODUCT DEFICIENCY WAS IDENTIFIED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

Description of Event or Problem

THIS REPORT SUMMARIZES 12 MALFUNCTION EVENTS. THE EVENT WAS RELATED TO SUCTION LOSS DURING LASER FIRE. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.