FDA Adverse Event
Injury
Summary report: N
SERENGETI DRIVERS SUNGLASSES
MDR report key: 38005
·
Received September 9, 1996
Report
- Report Number
- 1317452-1996-00004
- Event Type
- Injury
- Date Received
- September 9, 1996
- Date of Event
- June 13, 1996
- Report Date
- September 6, 1996
- Manufacturer
- CORNING INCORPORATED
- Product Code
- HQY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SERENGETI DRIVERS SUNGLASSES | SUNGLASS | HQY | CORNING INCORPORATED | NA | 5225 R |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Required Intervention |