MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-30 for FLUOROCON 8.07/9.5 DIAM -3.00 DIOPTER manufactured by Pilkington Barnes Hind, Inc..
[21693966]
This lens was never disposed to the pt. Base curve verification was 8/12 instead of 8/07, well beyond accepted tolerance of good mfg practices and ansi standards. This was supposed to have been re-inspected for accuracy before shipment. Corneal health could have been seriously compromised by this poor quality control
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1001326 |
| MDR Report Key | 12404 |
| Date Received | 1994-03-30 |
| Date of Report | 1994-03-28 |
| Date Added to Maude | 1994-03-31 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLUOROCON |
| Generic Name | RIGID GAS PERMEABLE CONTACT LENS |
| Product Code | HPX |
| Date Received | 1994-03-30 |
| Returned To Mfg | 1994-03-28 |
| Model Number | 8.07/9.5 DIAM |
| Catalog Number | -3.00 DIOPTER |
| Lot Number | ORDER #4898938/001 |
| Device Expiration Date | 1997-03-01 |
| Operator | OTHER |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 12404 |
| Manufacturer | PILKINGTON BARNES HIND, INC. |
| Manufacturer Address | SUNNYVALE CA 94086 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-03-30 |