MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-11-04 for EXAMPLE= LENSCRAFTERS "INVISIBLES" * manufactured by Lenscrafters.
[330664]
Lenscrafter - and every other optician and optometrist offering eyeglasses with "glare-free" or "non-glare coating - do not inform pts/customers in advance that coating wears off in several weeks time and leaves hundreds of scratches on lens surface. Lenscrafters calls them "invisibles".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1030053 |
| MDR Report Key | 494559 |
| Date Received | 2003-11-04 |
| Date of Report | 2003-10-30 |
| Date of Event | 1991-01-01 |
| Date Added to Maude | 2003-11-13 |
| 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 | 3 |
| Reporter Occupation | PATIENT |
| 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 | EXAMPLE= LENSCRAFTERS "INVISIBLES" |
| Generic Name | EYEGLASS LENS COATING |
| Product Code | HQG |
| Date Received | 2003-11-04 |
| Model Number | NA |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 483270 |
| Manufacturer | LENSCRAFTERS |
| Manufacturer Address | * MASON OH 45040 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-11-04 |