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 2020-02-17 for HEALON ENDOCOAT VT585U manufactured by Johnson & Johnson Surgical Vision, Inc..
[186750365]
Sex/gender: unknown/ not provided. If implanted; give date: not applicable as the healon endocoat is not an implantable device. If explanted; give date: not applicable as the healon endocoat is not an implantable device. Initial reporter's first name: unknown, not provided. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[186750366]
It was reported that the vial of the healon endocoat, model vt585u broke upon injecting the product into the patient's eye. That the surgeon placed the needle in the patient's eye to inject the endocoat and when advancing the plunger the vial broke. It was noted that the customer did not feel a lot of resistance and did not have to apply extra pressure that would have caused the vial to break. It was confirmed that the glass did not fall into the patient's eye, that the procedure was completed successfully and there was no patient injury reported. It was indicated that the device is available for return. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004750704-2020-00010 |
| MDR Report Key | 9718759 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-01-20 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-02-17 |
| 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 | RAPSGATAN |
| Manufacturer City | UPPSALA 751 82 |
| Manufacturer Country | SE |
| Manufacturer Postal Code | 751 82 |
| 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 | 2020-02-17 |
| Model Number | VT585U |
| Catalog Number | VT585U |
| Lot Number | 028106 |
| 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 | 2020-02-17 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-17 |