FS DISPOSABLE INTERFACE

Additional Manufacturer Narrative

DEVICE EVALUATION: THREE (3) INVESTIGATIONS WERE COMPLETED DURING THE PERIOD. FOR ONE (1) DEVICE THE VISUAL INSPECTION DID NOT REVEAL ANY OBVIOUS DEFECTS OR DAMAGE. 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. FUNCTIONALITY TEST WAS PERFORMED, AND THE RESULT WERE FOUND WITHIN SPECIFICATIONS. THE REPORTED EVENT WAS NOT CONFIRMED. FOR TWO (2) DEVICES VISUAL INSPECTIONS WERE DONE AND THE GRIPPER'S SEAL RING WAS BROKEN/DAMAGE. THIS COMPROMISED HE DEVICES ABILITY TO MAINTAIN THE VACUUM SEAL REQUIRED FOR PROPER DEVICE FUNCTIONALITY. THE DEVICES WERE FOUND WERE NOT WITHIN SPECIFICATIONS. BOTH DEVICES WERE MANUFACTURED PRIOR MAY 23RD, 2025 AND THEREFORE PRIOR TO THE IMPLEMENTATION OF CORRECTIVE ACTIONS BY THE SUPPLIER. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

Additional Manufacturer Narrative

H10 -LIST OF ALL SERIAL NUMBERS OF THE DEVICES AND QUANTITY (B)(6) (X6), (B)(6) (X5), (B)(6) (X5), (B)(6) (X4), (B)(6) (X4), (B)(6) (X4), UNKNOWN (X4), (B)(6) (X4), (B)(6) (X3), (B)(6) (X3), (B)(6) (X3), (B)(6) (X3), (B)(6) (X3), (B)(6) (X2), (B)(6) (X2), (B)(6) (X2), (B)(6) (X1), (B)(6) (X1), (B)(6) (X1), (B)(6) (X1), (B)(6) (X1), (B)(6) (X1), (B)(6) (X1), (B)(6) (X1), (B)(6) (X1), (B)(6) (X1), (B)(6) (X1), (B)(6) (X1), (B)(6) (X1), (B)(6) (X1), (B)(6) (X1), (B)(6) (X1), (B)(6) (X1). DEVICE EVALUATION: FIFTEEN (15) INVESTIGATIONS WERE COMPLETED DURING THE PERIOD. FOR SEVEN (7) OF THOSE THE PRODUCT WAS RETURNED AND A VISUAL INSPECTION DID NOT REVEAL ANY OBVIOUS DEFECTS OR DAMAGE. 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. FOR EIGHT (8) OF THOSE THE PRODUCT WAS NOT RETURNED. 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 74 MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO SUCTION LOSS WHILE LASER FIRING. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

Additional Manufacturer Narrative

DEVICE EVALUATION: TWENTY-NINE (29) INVESTIGATIONS WERE COMPLETED DURING THE PERIOD. A REVIEW OF THE RECORDS RELATED TO THE DEVICES THAT INCLUDED LABELING, MANUALS, TRENDING, RISK DOCUMENTATION AND DEVICE HISTORY RECORD (DHR) SHOWED 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.

Additional Manufacturer Narrative

DEVICE EVALUATION: TWO (2) INVESTIGATIONS WERE COMPLETED DURING THE PERIOD. A REVIEW OF THE RECORDS RELATED TO THE DEVICE 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.

Additional Manufacturer Narrative

DEVICE EVALUATION: EIGHTEEN (18) 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 NOT 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.