MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 1996-10-18 for CEEON UV-ABSORBING SILICONE LENS 920 UNK manufactured by Pharmacia Iovision, Inc..
[7765317]
An investigation of batch records showed that all release criteria were met. Manufacturer conclusion: no product defect found. No further information is expected.
Patient Sequence No: 1, Text Type: N, H10
[17110301]
"the lens split once inside the pt's eye". No other details were provided. In follow-up with the initial reporter, the lens remain "in situ" and the crack occurred in the haptic not in the visual field. The surgeon did not wish to provide any add'l info.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2083358-1996-00004 |
| MDR Report Key | 44810 |
| Report Source | 01,05,07 |
| Date Received | 1996-10-18 |
| Date of Report | 1996-10-18 |
| Date Mfgr Received | 1996-10-16 |
| Date Added to Maude | 1996-10-29 |
| 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 SILICONE LENS |
| Generic Name | INTRAOCULAR LENS |
| Product Code | HOL |
| Date Received | 1996-10-18 |
| Model Number | 920 |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 45720 |
| 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 | 1996-10-18 |