CATALYS SYSTEM
Received Mar 17, 2026 · Event occurred Feb 20, 2026
Report 3012236936-2026-000069 · MDR key 24620050
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 · Unknown
- Capsular Bag Tear
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A FEMTO TREATMENT DURING WHICH THE POSTERIOR CAPSULE SPLIT WHILE PHACOEMULSIFICATION WAS BEING PERFORMED. AT THE TIME OF THE INCIDENT, APPROXIMATELY 90% OF THE LENS REMAINED TO BE REMOVED. THE PHYSICIAN SUCCESSFULLY EXTRACTED MOST OF THE LENS AND PLACED A LENS IN THE EYE USING REVERSE OPTIC CAPTURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
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. 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.