MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1996-11-15 for CEEON UV-ABSORBING PC IOL 920 UNK manufactured by Pharmacia Iovision, Inc..
[30149]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2083358-1996-00007 |
| MDR Report Key | 50195 |
| Report Source | 05 |
| Date Received | 1996-11-15 |
| Date of Report | 1996-11-13 |
| Date Mfgr Received | 1996-10-08 |
| Date Added to Maude | 1996-11-21 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CEEON UV-ABSORBING PC IOL |
| Generic Name | IOL |
| Product Code | HOL |
| Date Received | 1996-11-15 |
| Model Number | 920 |
| Catalog Number | UNK |
| Lot Number | 920 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 50909 |
| Manufacturer | PHARMACIA IOVISION, INC. |
| Manufacturer Address | 15350 BARRANCA PKWY IRVINE CA 92718 US |
| Baseline Brand Name | CEEON |
| Baseline Generic Name | INTRAOCULAR LENS |
| Baseline Model No | 920 |
| Baseline Catalog No | NA |
| Baseline ID | WS127 |
| Baseline Device Family | PLIOLENS, MODEL WS100 |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 48 |
| Baseline PMA Flag | Y |
| Premarket Approval | P9400 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-11-15 |