MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-10 for PROVISC OPHTHALMIC VISCOSURGICAL DEVICE manufactured by Alcon - Couvreur N.v./alcon - Belgium.
| Report Number | 3002037047-2020-00005 |
| MDR Report Key | 9812098 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-03-10 |
| 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 | MR. JONATHAN SCHLECH |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175514979 |
| Manufacturer G1 | ALCON - COUVREUR N.V./ALCON - BELGIUM |
| Manufacturer Street | RIJKSWEG 14 |
| Manufacturer City | PUURS B-2870 |
| Manufacturer Country | BE |
| Manufacturer Postal Code | B-2870 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROVISC OPHTHALMIC VISCOSURGICAL DEVICE |
| Generic Name | AID, SURGICAL, VISCOELASTIC |
| Product Code | LZP |
| Date Received | 2020-03-10 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | 19H06D |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON - COUVREUR N.V./ALCON - BELGIUM |
| Manufacturer Address | RIJKSWEG 14 PUURS B-2870 BE B-2870 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-10 |