MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-12-20 for HEALON ENDOCOAT VT585 manufactured by Johnson & Johnson Surgical Vision, Inc..
[187773022]
Implant and explant date: if implanted or explanted, give date: not applicable, the healon endocoat is not an implantable device. Other: the device is not returning for evaluation, model and lot number are unknown, not provided, therefore no product investigation can be performed. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[187773023]
It was reported that healon endocoat product was used during cataract surgery and was not removed by the doctor. There was no adverse effect except for six (6) hours after intraocular lens (iol) replacement when corneal decompensation developed, the cornea became opaque. There was no increase in intraocular pressure. No product will be returned. No other information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004750704-2019-00112 |
| MDR Report Key | 9501869 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-12-20 |
| Date of Report | 2020-03-09 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-11 |
| Date Added to Maude | 2019-12-20 |
| 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 | 3515 LYMAN BOULEVARD |
| Manufacturer City | CHASKA MN 55318 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55318 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEALON ENDOCOAT |
| Generic Name | OVDS |
| Product Code | LZP |
| Date Received | 2019-12-20 |
| Model Number | VT585 |
| Catalog Number | VT585 |
| Lot Number | 027344 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2019-12-20 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-12-20 |