MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-03-28 for ALCON 3655-23 * manufactured by Alcon.
[18332570]
Cornea protector left a white circle on pt's eye when removed. Pt's eye required scraping of epithelium to remove.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1021506 |
| MDR Report Key | 323508 |
| Date Received | 2001-03-28 |
| Date of Event | 2001-03-15 |
| Date Added to Maude | 2001-04-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALCON |
| Generic Name | CORNEA PROTECTOR |
| Product Code | MOE |
| Date Received | 2001-03-28 |
| Model Number | 3655-23 |
| Catalog Number | * |
| Lot Number | 190245 H |
| ID Number | * |
| Device Expiration Date | 2001-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 312988 |
| Manufacturer | ALCON |
| Manufacturer Address | 2650 W BELLFORT ST HOUSTON TX 770549862 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-03-28 |