FDA Adverse Event
Malfunction
Summary report: Y
CATALYS LASER
MDR report key: 18576820
·
Received January 24, 2024
Report
- Report Number
- 3012236936-2024-00188
- Event Type
- Malfunction
- Date Received
- January 24, 2024
- Date of Event
- November 8, 2023
- Report Date
- January 24, 2024
- Manufacturer
- JOHNSON & JOHNSON SURGICAL VISION, INC.
- Product Code
- OOE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
E1: PHONE NUMBER: (B)(6). G4: 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. THE INVESTIGATION WAS COMPLETED DURING THE PERIOD. A REVIEW OF THE RECORDS RELATED TO THE DEVICE THAT INCLUDED LABELING, MANUALS, TRENDING, RISK DOCUMENTATION AND DEVICE HISTORY RECORD (DHR) SHOWED THAT THE SYSTEM AND ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. NO PRODUCT DEFICIENCY WAS IDENTIFIED.
Description of Event or Problem · 0
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT. THE EVENT WAS RELATED TO SUCTION LOSS WHILE LASER FRYING. THERE WAS NO PATIENT INJURY REPORTED ASSOCIATED TO THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1247444 | CATALYS LASER | OPHTHALMIC FEMTOSECOND LASER | OOE | JOHNSON & JOHNSON SURGICAL VISION, INC. | CATALYS-C |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |