MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-01-10 for PROVISC OPHTHALMIC VISCOSURGICAL DEVICE manufactured by Alcon - Couvreur N.v./alcon - Belgium.
[174729728]
Regulatory assessment for reporting complete.? With current information, this report of endophthalmitis meets criteria for reporting based on applicable medical device regulations. Exemptions may apply nbrown. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[174729729]
A health professional reported that after an intraocular lens (iol) implant procedure, a patient experienced endophthalmitis. Additional information has been requested. This is one of two reports from this facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002037047-2020-00001 |
| MDR Report Key | 9577826 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-01-10 |
| Date of Report | 2020-01-10 |
| Date of Event | 2019-11-26 |
| Date Mfgr Received | 2019-12-17 |
| Date Added to Maude | 2020-01-10 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JASON MICHAELIDES |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175686438 |
| 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 | 2020-01-10 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | ASKU |
| 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 | 2020-01-10 |