CATALYS SYSTEM
Report
- Report Number
- 3005675890-2018-00084
- Event Type
- Injury
- Date Received
- October 3, 2018
- Date of Event
- September 6, 2018
- Report Date
- November 3, 2020
- Manufacturer
- JOHNSON & JOHNSON SURGICAL VISION, INC
- Product Code
- OOE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
THIS CORRECTION MDR IS BEING SUBMITTED TO ADDRESS INACCURATE INFORMATION IN SECTION F ON THE XML VERSION OF THE PREVIOUS SUBMISSION CAUSED BY A SOFTWARE GLITCH IN THE TRANSMISSION PROCESS. THE INTERNAL NON-CONFORMANCE NUMBERS FOR THIS SOFTWARE ISSUE ARE NR-0148919 AND CAPA-010215.
CORRECTION -MANUFACTURING SITE REPORTED THE DATE TO BE MAY 2017.
THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT; LASER CORRECTION SYSTEM, MODEL CATALYS-I, THAT HAS A SIMILAR PRODUCT, CATALYS-U WHICH IS DISTRIBUTED IN THE UNITED STATES UNDER 510(K) # K121091. MANUFACTURING YEAR 2016. THE SYSTEM WAS EVALUATED BY A FIELD SERVICE ENGINEER. THE FIELD SERVICE FOUND NO ISSUES WITH THE UNIT. A FIELD SERVICE CHECKLIST WAS PERFORMED AND ANNUAL PREVENTATIVE MAINTENANCE. THE UNIT COMPLIED WITH ALL FACTORY SETTINGS. A REVIEW OF RECORDS RELATED TO THE DEVICE INCLUDING LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION WILL BE PERFORMED. UPON COMPLETION OF THIS REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.
IT WAS REPORTED THAT PATIENT HAD A CAPSULE TEAR. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 772163 | CATALYS SYSTEM | CATALYS | OOE | JOHNSON & JOHNSON SURGICAL VISION, INC | CATALYS-I |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |