MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1998-08-26 for VISUAL HEALTHWEAR INSTANT SUNGLASSES REGULAR manufactured by Yorktowne Optical Co., Inc. Midlantic Accessories Co..
[98824]
Consumer suffered corneal abrasion after inserting onto eyeglasses. The reported incident occurred in aruba, but the sunglasses were purchased in manchester, connecticut at a store.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2513853-1998-00001 |
| MDR Report Key | 184346 |
| Report Source | 00 |
| Date Received | 1998-08-26 |
| Date of Report | 1998-08-03 |
| Date of Event | 1995-09-15 |
| Date Mfgr Received | 1998-07-31 |
| Date Added to Maude | 1998-08-31 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VISUAL HEALTHWEAR INSTANT SUNGLASSES |
| Generic Name | SUNGLASSES |
| Product Code | HQY |
| Date Received | 1998-08-26 |
| Model Number | REGULAR |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 179195 |
| Manufacturer | YORKTOWNE OPTICAL CO., INC. MIDLANTIC ACCESSORIES CO. |
| Manufacturer Address | P.O. BOX 276 EMIGSVILLE PA 173180276 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-08-26 |