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..
[67142]
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, right eye 7/23/97. Subsequently, she developed endophthalmitis (date unk). She was treated pre and post operatively with tobrex drops. This man was sent to a retinal specialist. The eye surgery center has conducted an internal investigation to determine a cause, however, no source of the infection could be found. A mfr review of the batch records did not reveal any discrepancies. All acceptance and release criteria were met. No further information is expected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2083358-1997-00008 |
| MDR Report Key | 118576 |
| Report Source | 05,06 |
| Date Received | 1997-09-05 |
| Date of Report | 1997-08-07 |
| Date of Event | 1997-01-01 |
| 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 | 116271 |
| Manufacturer | PHARMACIA IOVISION, INC. |
| Manufacturer Address | 15350 BARRANCA PARKMAUCHLY ST. 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 |