MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-11-17 for CEEON UV-ABSORBING LENS 920 NA manufactured by Pharmacia Iovision.
[74747]
This report was received from an ophthalmologist of a woman who underwent a cataract extraction with implantation of the model 920 uv-absorbing silicone iol into her right eye. Post surgery, she complained of a persistent ache in her eye. She was found to have a persistent mild iritis despite the normal course of steroid treatment following surgery. She continues to be on a slowly tapering dose of topical steroids and appears to be improving. The physician is concerned that there may be a possibility of a smoldering, late endophthalmitis. She continues to be followed closely. Add'l info is being sought as to whether the pt did develop an endophthalmitis, add'l treatment and final outcome of the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2083358-1997-00013 |
| MDR Report Key | 133420 |
| Report Source | 05 |
| Date Received | 1997-11-17 |
| Date of Report | 1997-10-22 |
| Date of Event | 1997-08-01 |
| Date Mfgr Received | 1997-10-21 |
| Device Manufacturer Date | 1996-07-01 |
| Date Added to Maude | 1997-11-21 |
| 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 LENS |
| Generic Name | INTRAOCULAR LENS |
| Product Code | HOL |
| Date Received | 1997-11-17 |
| Model Number | 920 |
| Catalog Number | NA |
| Lot Number | 97090015 |
| 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 | 130392 |
| Manufacturer | PHARMACIA IOVISION |
| Manufacturer Address | 15350 BARRANCA PARKWAY IRVINE CA 926197047 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 | 1997-11-17 |