MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1996-09-09 for SERENGETI DRIVERS SUNGLASSES DR 5225 manufactured by Corning Incorporated.
[20615]
A consumer put on a pair of co's sunglasses. Left lens was apparently cracked. While placing the glasses on his face and opening the temples a chip from the lens struck his left eye causing irritation. Medical attention was sought and a corneal scratch was diagnosed. The eye was treated, and the scratch has since healed, and no further treatment is taking place.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1317452-1996-00004 |
| MDR Report Key | 38005 |
| Report Source | 04 |
| Date Received | 1996-09-09 |
| Date of Report | 1996-09-06 |
| Date of Event | 1996-06-13 |
| Date Mfgr Received | 1996-08-14 |
| Date Added to Maude | 1996-09-17 |
| 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 | 3 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SERENGETI DRIVERS SUNGLASSES |
| Generic Name | SUNGLASS |
| Product Code | HQY |
| Date Received | 1996-09-09 |
| Returned To Mfg | 1996-08-14 |
| Model Number | NA |
| Catalog Number | DR 5225 |
| Lot Number | 5225 R |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 39278 |
| Manufacturer | CORNING INCORPORATED |
| Manufacturer Address | 203 COLONIAL DR HORSEHEADS NY 14845 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-09-09 |