CATALYS SYSTEM
Received Jul 16, 2026 · Event occurred Jun 22, 2026
Report 3012236936-2026-000210 · MDR key 25850125
Device
Generic name
Ophthalmic Femtosecond Laser
Manufacturer
Amo Manufacturing Usa, LlcModel number
CATALYS-UCatalog number
CATALYS-U
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
67 YR · Male
- Capsular Bag Tear
Narrative
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.
Description of Event or Problem
IT WAS REPORTED THAT PATIENT'S RIGHT EYE HAD A POSTERIOR CHAMBER BLOWOUT THAT OCCURRED DURING HYDRODISSECTION. SURGEON WAS ABLE TO RETAIN ALL FRAGMENTS WITHOUT VITRECTOMY. 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.