CATALYS SYSTEM
Report
- Report Number
- 3012236936-2023-01947
- Event Type
- Malfunction
- Date Received
- July 28, 2023
- Report Date
- October 30, 2023
- Manufacturer
- JOHNSON & JOHNSON SURGICAL VISION, INC.
- Product Code
- OOE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ADDITIONAL INFORMATION: ONE INVESTIGATION WAS COMPLETED DURING THE REPORTING PERIOD. NO PRODUCT DEFICIENCY WAS IDENTIFIED.
PMA/510K: THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT; LASER CORRECTION SYSTEM, MODEL CATALYS-C, THAT HAS A SIMILAR PRODUCT, CATALYS-U WHICH IS DISTRIBUTED IN THE UNITED STATES UNDER 510(K) # K113479. ONE (1) INVESTIGATION WAS COMPLETED DURING THE PERIOD. NO PRODUCT DEFICIENCY WAS IDENTIFIED. A REVIEW OF THE RECORDS RELATED TO THE DEVICE THAT INCLUDED LABELING, MANUALS, TRENDING, AND RISK DOCUMENTATION REVIEWS WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWED THAT THE SYSTEM AND ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. THE RISKS AND MITIGATIONS ASSOCIATED WITH THE COMPLAINT ISSUE ARE IDENTIFIED IN EXISTING RISK DOCUMENTS AND NO NEW RISKS WERE IDENTIFIED AS PART OF THIS INVESTIGATION. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT. THE EVENT WAS RELATED TO SUCTION LOSS DURING LASER FIRING. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1946240 | CATALYS SYSTEM | OPHTHALMIC FEMTOSECOND LASER | OOE | JOHNSON & JOHNSON SURGICAL VISION, INC. | CATALYS-C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |