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. DEVICE EVALUATION: A FIELD SERVICE ENGINEER (FSE) VISITED SITE AND MADE ADJUSTMENTS TO SYSTEM AND IMPROVED POWER TO ATTENUATOR AND PERFORMED EXTERNAL POWER CALIBRATION. MULTIPLE DAILY ALIGNMENT VERIFICATIONS WERE PERFORMED AND ONE MOCK TREATMENT COMPLETED WITHOUT ISSUE. SYSTEM IS PERFORMING TO SPECIFICATION. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC HAS BEEN SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THERE WERE BUBBLES DURING DAILY ALIGNMENT VERIFICATION OF THE CATALYS LASER. IT WAS ALSO REPORTED THAT PATIENT HAD TAGS DURING CAPSULOTOMY. PATIENT HAD AN ANTERIOR VITRECTOMY PERFORMED AND THE REASON WHY VITRECTOMY WAS PERFORMED WAS NOT PROVIDED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY IN THE SAME VISIT. NO ADDITIONAL INFORMATION WAS PROVIDED.