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.
[17108400]
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. Approx one week after surgery, she was noted to have reduced vision of 20/60 with significant wrinkling and opacification of the posterior capsule. No macular edema was seen. The pt will need yag laser to improve her vision. Add'l info is being sought from the physician as to which eye was affected, date of yag laser treatment, other treatment required, final outcome, and is the pt's reduced vision considered to be sight threatening-permanent or temporary.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2083358-1997-00014 |
| MDR Report Key | 133436 |
| 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 | 130408 |
| Manufacturer | PHARMACIA IOVISION |
| Manufacturer Address | 15350 BARRANCA PKWY. 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. Required No Informationntervention | 1997-11-17 |