CATALYS SYSTEM
Received Feb 27, 2026 · Event occurred Jan 21, 2026
Report 3012236936-2026-000041 · MDR key 24470715
Device
Generic name
Ophthalmic Femtosecond Laser
Manufacturer
Amo Manufacturing Usa, LlcModel number
0160-6010Catalog number
0160-6010
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SECTION A2, A3A, A3B, A4, A5, A6: PER REGULATION EU 2016/679 (GENERAL DATA PROTECTION REGULATION), PATIENT IDENTIFIERS WERE NOT COLLECTED OR RECORDED AND THEREFORE ARE NOT AVAILABLE. SECTION D6: IMPLANT DATE: NOT APPLICABLE. THE CATALYS SYSTEM IS NOT AN IMPLANTABLE DEVICE. SECTION D6: EXPLANT DATE: NOT APPLICABLE. THE CATALYS SYSTEM IS NOT AN IMPLANTABLE DEVICE; THEREFORE, NOT EXPLANTED. SECTION E1: TELEPHONE NUMBER: (B)(6). SECTION H: 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 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 AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT AN INCOMPLETE CAPSULORHEXIS OCCURRED ON THE PATIENT'S LEFT EYE (OS). THERE WAS A 4 HOUR DELAY. IT WAS MANAGED SUCCESSFULLY WITH MICRO SCISSORS AND MANUAL COMPLETION. THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE CAPSULAR BAG. THROUGH ADDITIONAL INFORMATION WE LEARNED THERE WAS NO MEDICAL OR SURGICAL INTERVENTION OUTSIDE THE STANDARD OF CARE. NO FURTHER INFORMATION WAS REPORTED.