FS DISPOSABLE INTERFACE

Additional Manufacturer Narrative

DEVICE EVALUATION: THIRTY (30) INVESTIGATIONS WERE COMPLETED DURING THE PERIOD. ALL INVESTIGATIONS HAD PRODUCT 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 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. 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 60522725 (B)(4). 60554539 (B)(4). 60598395 (B)(4). 60598396 (B)(4). 60606549 (B)(4). 60613609 (B)(4). 60617988 (B)(4). 60593091 (B)(4). 60614979 (B)(4). 60499862 (B)(4). UNKNOWN (B)(4). 60597055 (B)(4). 60595022 (B)(4). 60586717 (B)(4). 60567511 (B)(4). 60595023 (B)(4). 60550672 (B)(4). 60573860 (B)(4). 60613541 (B)(4). 60559173 (B)(4). DEVICE EVALUATION: SIX (6) INVESTIGATIONS WERE COMPLETED DURING THE PERIOD. NO PRODUCT DEFICIENCY WAS IDENTIFIED. A REVIEW OF THE RECORDS RELATED TO THE DEVICE THAT INCLUDED LABELING, MANUALS, TRENDING WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT THE DEVICE AND ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. . 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 59 MALFUNCTION EVENTS. THE EVENT WAS RELATED TO SUCTION LOSS WHILE LASER FIRING. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.