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.
[182709601]
No sample has been received by manufacturing for evaluation. Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[182709603]
A physician reported that a viscoelastic cannula with a possible burr was used during a cataract with intraocular lens implantation surgery when the posterior capsule was ruptured requiring that an alternate lens be used in the procedure. Additional information has been requested. Additional information received clarified that after the alternate lens was implanted into the patient's left eye, there were no further complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002037047-2020-00004 |
| MDR Report Key | 9810832 |
| 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 |