MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-03-24 for FLUOROCON 8.15/9.5 DIAM -600 DIOPTER manufactured by Pilkington Barnes-hind, Inc..
[8619]
Product was never dispensed to the pt. Verification of base curve of lens resulted in rptr's rejection of the product. Base curve is labeled 8. 15. It verifies as 8. 20, well beyond tolerance. Corneal health could have been compromised by this poor quality control.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1001206 |
| MDR Report Key | 12249 |
| Date Received | 1994-03-24 |
| Date of Report | 1994-03-22 |
| Date Added to Maude | 1994-03-25 |
| 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 | 1994-03-24 |
| Returned To Mfg | 1994-03-22 |
| Model Number | 8.15/9.5 DIAM |
| Catalog Number | -600 DIOPTER |
| Lot Number | HABJR |
| Device Expiration Date | 1997-08-01 |
| Operator | OTHER |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 12249 |
| Manufacturer | PILKINGTON BARNES-HIND, INC. |
| Manufacturer Address | SUNNYVALE CA 94086 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-03-24 |