CATALYS SYSTEM

Additional Manufacturer Narrative

SECTION A2 A3, A4 AND A5: UNKNOWN/ NOT PROVIDED. SECTION D6A: IF IMPLANTED, GIVE DATE: NOT APPLICABLE, AS THE DEVICE IS NOT AN IMPLANTABLE. SECTION D6B: IF EXPLANTED, GIVE DATE: NOT APPLICABLE, AS THE DEVICE IS NOT AN IMPLANTABLE. SECTION H3: THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. A REVIEW OF RECORDS INCLUDING DEVICE HISTORY RECORD AND COMPLAINT TRENDING WILL BE PERFORMED. UPON COMPLETION OF THE REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A SUCTION LOSS OCCURRED TWICE BETWEEN INTEGRAL GUIDANCE SCANNING (PRIOR TO LASER FIRING) AND ONCE DURING LASER TREATMENT. THEY VERIFIED EACH TIME THAT THE PATIENT WAS NOT MOVING OR SQUEEZING. THEY WERE NOT ABLE TO COMPLETE SEXTANTS OR INTRASTROMAL MARKS. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. NOTE: THIS REPORT IS AGAINST THE CATALYS SYSTEM. A SEPARATE REPORT WILL BE FILED AGAINST THE LIQUID OPTICS INTERFACE (LOI).