CATALYS SYSTEM

Description of Event or Problem

IT WAS REPORTED THAT PATIENT'S RIGHT EYE HAD A SUCTION LOSS WARNING CLEARABLE ERROR DURING FEMTO. SURGEON CHOSE TO COMPLETE FEMTO TREATMENT AFTER CLEARING ERROR. SURGEON SAID THERE WAS A NOTICEABLE AIR BUBBLE IN THE SUCTION RING INTERFACE. SURGEON ENDED UP HAVING TO DO A VITRECTOMY DURING CASE DUE TO POSTERIOR CHAMBER BLOWOUT. NO RETINA INTERVENTION REQUIRED. SURGEON IMPLANTED 3-PIECE INTRAOCULAR LENS (IOL) INSTEAD OF A POSTERIOR CHAMBER (PC-IOL) AS INTENDED. PATIENT IS DOING WELL POSTOPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED. NOTE: THIS REPORT IS FOR THE CATALYS SYSTEM. A SEPARATE REPORT WILL FILED AGAINST THE LIQUID OPTICS INTERFACE.

Additional Manufacturer Narrative

SECTION A4 : 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.