MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 1996-09-26 for CEEON UV-ABSORBING LENS 920 UNK manufactured by Pharmacia Iovision Inc.
[40564]
Investigation by the mfr consisted of a video that was reviewed and evaluated by a consultant. It was the opinion of the consultant. It was the opinion of the consultant that it was apparent that the pt sustained a "capsular block phenomenon". This complication is more related to capsulorhexis then it is to any given lens implant. The observed situation was caused by the surgical procedure. No further info is expected.
Patient Sequence No: 1, Text Type: D, B5
[15587913]
Note that this report was received by pharmacia iovision on 1/4/96. It was brought to the attention of corporate pharmacovigilance (cpv) on 9/12/96 from sweden. The consultant opinion of the report was received at pharmacia iovision on 7/16/96 and forwarded to cpv on 9/27/96. This should clarify manufactrer receive dates.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2083358-1996-00003 |
| MDR Report Key | 40314 |
| Report Source | 01,05 |
| Date Received | 1996-09-26 |
| Date of Report | 1996-09-26 |
| Date Mfgr Received | 1996-07-16 |
| Date Added to Maude | 1996-10-03 |
| 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 LENS |
| Generic Name | SILICON PC IOL |
| Product Code | HOL |
| Date Received | 1996-09-26 |
| 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 | 41432 |
| 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; 2. Required No Informationntervention | 1996-09-26 |