FS DISPOSABLE INTERFACE

Additional Manufacturer Narrative

DEVICE EVALUATION: (27) INVESTIGATIONS WERE COMPLETED DURING THE PERIOD. FOR (19) OF THOSE THE PRODUCT WERE RETURNED AND (8) WERE NOT. FROM THE RETURNED PRODUCTS THE FOLLOWING WAS FOUND: FOR (17) VISUAL INSPECTION DID NOT REVEAL ANY OBVIOUS DEFECTS OR DAMAGE. FUNCTIONALITY TEST WERE PERFORMED, AND THE RESULTS WERE FOUND WITHIN SPECIFICATIONS. THE REPORTED EVENT WAS NOT CONFIRMED. FOR (2) THE PRODUCTS WERE RECEIVED MIXED AND WE WERE UNABLE TO IDENTIFY THE LOT NUMBERS WITH THE CORRESPONDING INVESTIGATIONS. (8) PRODUCTS WERE NOT RETURNED. FOR ALL INVESTIGATIONS A REVIEW OF THE RECORDS RELATED TO THE DEVICES THAT INCLUDED LABELING AND TRENDING WAS PERFORMED AND 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

LOT NUMBERS OF THE DEVICES AND QUANTITY: 60567517, (X2). 60570253, (X1). 60573865, (X3). 60586717, (X4). 60588728, (X2). 60593091, (X3). 60595022, (X3). 60598395, (X4). 60613609, (X1). 60614979, (X1). 60616763, (X1). 60617988, (X6). 60625523, (X1). 60652931, (X1). 60658844, (X1). 60682147, (X2). FIVE (5) INVESTIGATIONS WERE COMPLETED DURING THE PERIOD. ALL 5 INVESTIGATIONS HAD PRODUCT RETURNED. VISUAL INSPECTIONS DID NOT REVEAL ANY OBVIOUS DEFECTS OR DAMAGES. FUNCTIONALITY TESTS WERE PERFORMED, AND THE RESULTS WERE FOUND WITHIN SPECIFICATIONS. THE REPORTED EVENT IS CONFIRMED. A REVIEW OF THE RECORDS RELATED TO THE DEVICE THAT INCLUDED LABELING, MANUALS, TRENDING, AND DEVICE HISTORY RECORD (DHR) SHOWED THAT THE DEVICE AND ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. NO PRODUCT DEFICIENCY WAS IDENTIFIED. THE PATIENT INTERFACE (PI) SUCTION RING MAY LOSE SUCTION DURING A PROCEDURE. LABEL COPY STATES CORNEAL FIXATION VACUUM LOSS CAN OCCUR. THERE ARE SEVERAL FACTORS THAT MAY CONTRIBUTE TO SUCTION ISSUES SUCH AS DOCTOR¿S TECHNIQUE IN APPLYING THE SUCTION RING TO THE CORNEA, DOCTOR¿S TECHNIQUE IN SQUEEZING THE PI CLIP TO SECURE THE SUCTION RING TO THE PI CONE AND PATIENT ANATOMY AFFECTING THE INTERFACE BETWEEN THE PATIENT¿S CORNEA AND THE SUCTION RING. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

Description of Event or Problem

THIS REPORT SUMMARIZES 36 MALFUNCTION EVENTS. THE EVENT WAS RELATED TO SUCTION LOSS WHILE LASER FIRING. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.