CATALYS SYSTEM
Received Feb 12, 2026 · Event occurred Jan 22, 2026
Report 3012236936-2026-000041 · MDR key 24327396
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
NA · Female
- Capsular Bag Tear
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: SECTION H3 DEVICE EVALUATED BY MANUFACTURER: YES. DEVICE EVALUATION: DEVICE EVALUATION: A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO SERVICE THE SYSTEM AND PERFORMED A PREVENTATIVE MAINTENANCE (PM). SYSTEM PERFORMING TO SPECIFICATION. MANUFACTURING RECORDS REVIEW: THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED. THE PRODUCT WAS MANUFACTURED AND RELEASED ACCORDING TO SPECIFICATION. CONCLUSION: AS A RESULT OF THE INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.
Additional Manufacturer Narrative
SECTION A4 AND A5: UNKNOWN/ NOT PROVIDED. . 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 HAD A CAPSULAR TEAR ON THE RIGHT EYE. THE CATARACT WAS 2+ NUCLEAR SCLEROSIS AND 3+ NUCLEAR SCLEROSIS. THERE WAS A PREVIOUS PTERYGIUM SURGERY THAT WAS PERFORMED ON (B)(6) 2025. NO ADDITIONAL INFORMATION WAS PROVIDED.