MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-12-13 for CRIZAL * manufactured by Essilor Intl Essilor Of America, Inc..
[200077]
Created unsafe driving conditions due to blurring of vision. After one month of use lenses developed tiny circular scratch marks. Pt was very careful to use only the supplied cleaning cloth to clean lenses.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1020652 |
| MDR Report Key | 309553 |
| Date Received | 2000-12-13 |
| Date of Report | 2000-11-26 |
| Date Added to Maude | 2000-12-27 |
| 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 | MEDICAL TECHNOLOGIST |
| 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 | CRIZAL |
| Generic Name | ANTI-REFLECTIVE LENSE COATING |
| Product Code | HQG |
| Date Received | 2000-12-13 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 299499 |
| Manufacturer | ESSILOR INTL ESSILOR OF AMERICA, INC. |
| Manufacturer Address | 2400 118TH AVE NORTH ST PETERSBURG FL 33716 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-12-13 |