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 2020-03-05 for CATALYS SYSTEM CATALYS-U manufactured by Johnson & Johnson Surgical Vision, Inc..
[182175964]
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.
Patient Sequence No: 1, Text Type: N, H10
[182175965]
The surgery center reported that catalys femtosecond laser was completed on the left eye without issue. However, during the cataract extraction surgery in the operating room, a fragmented piece of the nucleus fell in the posterior bag. The incision was enlarged, and a partial vitrectomy was performed. An intraocular lens (iol) was successfully implanted in the sulcus.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005675890-2020-00010 |
| MDR Report Key | 9793256 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-05 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-02-13 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-14 |
| Date Added to Maude | 2020-03-05 |
| 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 | 1310 MOFFETT PARK DRIVE |
| Manufacturer City | SUNNYVALE CA 94089 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94089 |
| 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 | 2020-03-05 |
| 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 | 2020-03-05 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-05 |