CATALYS SYSTEM
Received Jul 2, 2026 · Event occurred Jun 8, 2026
Report 3012236936-2026-000196 · MDR key 25691923
Device
Generic name
Ophthalmic Femtosecond Laser
Manufacturer
Amo Manufacturing Usa, LlcModel number
CATALYS-UCatalog number
CATALYS-U
Product problems
- Computer Software Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A CATALYS ERROR: 05-024 L:OCK DISCREPANCY ERROR WITH PATIENT INVOLVEMENT. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED IN THE SAME VISIT. 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. DEVICE EVALUATION: A FIELD SERVICE ENGINEER (FSE) VISITED SITE AND ADJUSTED AND CALIBRATED BRAKE ASSEMBLY. PERFORMED LASER ENERGY AND POWER TEST. PERFORMED DAILY ALIGNMENT VERIFICATION (DAV) AND MOCK TREATMENT WITHOUT ANY ERRORS. SYSTEM PERFORMING TO SPECIFICATION. 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.