CATALYS SYSTEM
Received Jun 9, 2026
Report 3012236936-2026-000173 · MDR key 25446115
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
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SECTION A2 A3, A4 AND A5: UNKNOWN/ NOT PROVIDED. SECTION B3 DATE OF EVENT; 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: A FIELD SERVICE ENGINEER SPOKE WITH SITE WHO REPORTED THAT THEY ARE NOT HAVING ANY PROBLEMS WITH THE LASER OR HAD ANY PREVIOUS ISSUES. NO SERVICE WAS PERFORMED ON THE SYSTEM. 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 RADIAL TEAR AND CAPSULOTOMY SLIVERS IN UNKNOWN EYE AND A VITRECTOMY HAD TO BE PERFORMED DUE TO RADIAL TEAR. LASER WAS FIRING AT THE TIME OF THE INCIDENT. TREATMENT WAS COMPLETED SUCCESSFULLY WITHOUT ANY ERRORS. NO ADDITIONAL INFORMATION WAS PROVIDED.