FDA Adverse Event
Injury
Summary report: N
CEEON UV-ABSORBING PC IOL
MDR report key: 50195
·
Received November 15, 1996
Report
- Report Number
- 2083358-1996-00007
- Event Type
- Injury
- Date Received
- November 15, 1996
- Report Date
- November 13, 1996
- Manufacturer
- PHARMACIA IOVISION, INC.
- Product Code
- HOL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
CO WAS NOTIFIED BY AN OPHTHALMOLOGIST OF TWO WOMEN WHO DEVELOPED ENDOPHTHALMITIS AFTER IMPLANTATION OF UV-ABSORBING SILICONE LENS, MODEL 920. SPECIFIC INFO AS TO TREATMENT OR SURGICAL INTERVENTION WERE UNKNOWN AT OF THE INITIAL REPORT. ADD'L INFO AS TO EVAL OF THE ENDOPHTHALMITIS, TREATMENT AND OUTCOEM ARE BEING SOUGHT FROM THE OPHTHALMOLOGIST. MFR INVESTIGATION OF THE BATCH RECORDS WAS PERFORMED, ALL ACCEPTANCE CRITERIA WAS MET. LAB REPORTS WERE REINSPECTED AND NO DISCREPANCIES NOTED, AND ALL RELEASE CRITERIA WAS MET IN CONCLUSION, THE PRODUCT IS NOT RESPONSIBLE FOR ENDOPHTHALMITIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CEEON UV-ABSORBING PC IOL | IOL | HOL | PHARMACIA IOVISION, INC. | 920 | 920 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Required Intervention |