MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-05-09 for GAS PERMEABLE LENS UNK manufactured by Summit Optics Inc..
[19141420]
Base curvature beyond ansi (american national standards institute) standards. Diameters were off tolerance. Lenses were received with surface defects. Thickness was also beyond tolerance. Poor lenticular blends which create sharp angles. Problems were noted before pt. Use. Doctor has not received any evaluation results after returning product to the mfr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1011270 |
| MDR Report Key | 89602 |
| Date Received | 1997-05-09 |
| Date of Report | 1997-05-08 |
| Date of Event | 1997-02-03 |
| Date Added to Maude | 1997-05-13 |
| 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 | GAS PERMEABLE LENS |
| Generic Name | LENS |
| Product Code | HPX |
| Date Received | 1997-05-09 |
| Returned To Mfg | 1997-02-24 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | INVOICE-45753 44972 40697 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 88583 |
| Manufacturer | SUMMIT OPTICS INC. |
| Manufacturer Address | 2402 NORTHWEST 66 COURT GAINESVILLE FL 32653 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-05-09 |