MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-09-05 for CEEON LENS 920 UNK manufactured by Pharmacia Iovision, Inc..
[81051]
This report was received from an eye surgery center calling for info concerning infections occurring with intraocular lens implants with the model 920 uv-absorbing silicone foldable lens. A physician has had three occurrences of endophthalmitis associated with this model intraocular lens within the past two months. This particular woman had a phaco, clear corneal, cataract extraction, left eye 5/28/97. Subsequently, she developed endophthalmitis (date unk). She was treated pre and post operatively with tobrex drops. A culture was positive for strep and an antibiotic prescribed. The eye surgery center conducted an internal investigation to determine the cause, however, no source of the infection could be found. A mfr review of the batch records revealed that all release criteria were met, no discrepancies were noted in laboratory reports, and all release criteria were met. The results show that the product is not responsible for the endophthalmitis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2083358-1997-00006 |
| MDR Report Key | 118564 |
| Report Source | 05,06 |
| Date Received | 1997-09-05 |
| Date of Report | 1997-08-07 |
| Date of Event | 1997-06-01 |
| Date Facility Aware | 1997-06-02 |
| Date Reported to Mfgr | 1997-08-08 |
| Date Mfgr Received | 1997-08-08 |
| Date Added to Maude | 1997-09-11 |
| 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 LENS |
| Generic Name | UV-ABSORBING SILICONE FOLDABLE INTRAOCULAR LENS |
| Product Code | HOL |
| Date Received | 1997-09-05 |
| Model Number | 920 |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 116259 |
| Manufacturer | PHARMACIA IOVISION, INC. |
| Manufacturer Address | 15350 BARRANCA PARKWAY 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 | 1997-09-05 |