MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-31 for CATALYS SYSTEM CATALYS-U manufactured by Johnson & Johnson Surgical Vision, Inc..
[188732822]
A record review was performed. A product deficiency review was performed and there is no product deficiency identified. A document, service history, and trending was reviewed. There is not a recognizable adverse trend. 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. A labeling review was conducted; the operator manual for the system was reviewed and found to include adequate instructions for use, warnings and operational errors. The review of the device history record (dhr) for catalys system (s/n (b)(4)) showed that there were no issues or non-conformities. The system and its components met all specifications prior to being released. Manufacturing has been ruled out as a potential cause for the reported issue. Based on the investigation results, no corrective action has been issued. All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[188732823]
Customer reported vitreous was noted in the anterior capsule after the iol (intraocular lens) was implanted. An unplanned anterior vitrectomy was performed, and a capsular tension ring was implanted. The surgeon completed the procedure successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005675890-2020-00018 |
| MDR Report Key | 9904438 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-05 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-03-09 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SOMYATA NAGPAL |
| Manufacturer Street | 1700 EAST ST. ANDREW PLACE |
| Manufacturer City | SANTA ANA CA 92705 |
| Manufacturer Country | US |
| Manufacturer Postal | 92705 |
| Manufacturer Phone | 7142478200 |
| Manufacturer G1 | JOHNSON & JOHNSON SURGICAL VISION, INC. |
| Manufacturer Street | 510 COTTONWOOD DRIVE |
| Manufacturer City | MILPITAS CA 95035 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95035 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CATALYS SYSTEM |
| Generic Name | CATALYS |
| Product Code | OOE |
| Date Received | 2020-03-31 |
| Model Number | CATALYS-U |
| Catalog Number | CATALYS-U |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON SURGICAL VISION, INC. |
| Manufacturer Address | 1700 E ST ANDREW PLACE SANTA ANA CA 92705 US 92705 |
| Product Code | --- |
| Date Received | 2020-03-31 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-31 |