MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 1996-10-04 for CEE ON AV ABSORBING SILICONE LENS 920 NA manufactured by Pharmacia Iovision Inc.
[7826511]
On 12/6/96: during a follow-up conversation with sales representative to obtain the intraocular lens's for evaluation, he indicated that only one intraocular lens was returned to him and he had forwarded the lens to co's clayton facility for evaluation. He reported that the other lens was implanted into a pt's left eye. However, the physician denied implantation of any cracked lenses and his offfice nurse and surgery reported that they had returned both lenses to the sales representative to return to qa for evaluation. Corporate pharmacovigilance has reported the cracked lens according to the physcian story as both the physcian's office and other personnel maintained throughout the follow-up process that the lens had not been implanted and returned via the sales representative for evaluation. On 01/06/97, it was reported from co's clayton facility that one lens was received for evaluation. It was placed under a microscope and there was no evidence of pt contact and there was no visible crack in the optic. No furter information is expected.
Patient Sequence No: 1, Text Type: N, H10
[16756999]
Initially, this report was received from a sales rep of an ophthalmologist who reported cracking of the intraocular lens subsequently the ophthalmologist forwarded a letter to co stating that while folding the lens prior to insertion, the lens split with a crack involving the center of the lens. The lens was not implanted the ophthalmologist indicated that the lens was thick and he has had "several" that have cracked. He believed the product to be difficult to work with and the lens was not meeting his expectations. He indicated that he has used the same technique for many lens implants. He used a mcpherson angled forcep and locking inserter. Both lenses were from the same batch. Additional information is being sought from the md. Co is attempting to obtain the lenses for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2083358-1996-00005 |
| MDR Report Key | 58290 |
| Report Source | 05,07 |
| Date Received | 1996-10-04 |
| Date of Report | 1996-10-04 |
| Date of Event | 1996-08-01 |
| Date Mfgr Received | 1996-09-11 |
| Date Added to Maude | 1996-12-30 |
| 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 | CEE ON AV ABSORBING SILICONE LENS |
| Generic Name | INTRAOCULAR LENS |
| Product Code | HOL |
| Date Received | 1996-10-04 |
| Returned To Mfg | 1997-01-06 |
| Model Number | 920 |
| Catalog Number | NA |
| Lot Number | 000006882 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 58750 |
| 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. Other | 1996-10-04 |