MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-04-11 for "VARILUX" BRAND LENS * manufactured by Dr. David Kyle.
[18157257]
The sides of these brand lenses are prisms, not lenses. Only the center strip is ground lenses. Therefore everything to the (slightest) side appears to be airborn and furry.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1021620 |
| MDR Report Key | 326999 |
| Date Received | 2001-04-11 |
| Date of Event | 2001-01-01 |
| Date Added to Maude | 2001-04-18 |
| 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 | 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 | "VARILUX" BRAND LENS |
| Generic Name | GLASSES-PRESCRIPTION |
| Product Code | HQG |
| Date Received | 2001-04-11 |
| 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 | 316407 |
| Manufacturer | DR. DAVID KYLE |
| Manufacturer Address | 1055 W BARAGA MARQUETTE MI 49855 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention; 3. Deathisabilit | 2001-04-11 |