MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-02-01 for HEALON ENDOCOAT VT585U 57502000 manufactured by Johnson & Johnson Surgical Vision, Inc..
[185112516]
Age/date of birth: unknown/ not provided. Sex/gender: unknown/ not provided. If implanted; give date: n/a (not applicable). The healon is not an implantable device. If explanted; give date: n/a (not applicable). The healon is not an implantable device; therefore, not explanted. The healon was not returned for analysis; therefore, a failure analysis of the complaint device cannot be completed. A review of the device history record, and complaint trending for this device will be performed. Upon completion of the review, if there is any further relevant information 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
[185112517]
It was reported that a black ''fleck'' came out of the healon endocoat vt5854 initially into the patient's eye upon insertion. There was no adverse outcome noted. Customer also indicated that the product is not available for return. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004750704-2020-00004 |
| MDR Report Key | 9656455 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-02-01 |
| Date of Report | 2020-01-31 |
| Date of Event | 2020-01-02 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-01-06 |
| Date Added to Maude | 2020-02-01 |
| 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 | 2020-02-01 |
| Model Number | VT585U |
| Catalog Number | 57502000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-02-01 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-01 |