MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-09-17 for CEEON UV-ABSORBING SILICONE LENS 920 UNK manufactured by Pharmacia Iovision, Inc..
[101188]
This report was rec'd from a physician on the model 920 lens. She was attempting to fold the lens with a small inserter and the lens cracked. Pharmacia & upjohn has determined this to be a product malfunction as it is not in the labeling. The physician indicated that she did not implant this lens and would not implant in iol that she could see a defect in. Await results of a mfr batch review of this iol.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2083358-1997-00010 |
| MDR Report Key | 121892 |
| Report Source | 05 |
| Date Received | 1997-09-17 |
| Date of Report | 1997-08-21 |
| Date of Event | 1997-08-01 |
| Date Mfgr Received | 1997-08-21 |
| Date Added to Maude | 1997-09-25 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CEEON UV-ABSORBING SILICONE LENS |
| Generic Name | INTRAOCULAR LENS |
| Product Code | HOL |
| Date Received | 1997-09-17 |
| Model Number | 920 |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 119387 |
| 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. Other | 1997-09-17 |