MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-11-27 for ONSI 56 GAS PERMEABLE CONTACT LENS * manufactured by Lagado Corporation.
[394674]
Rigid gas permeable contact lens complication -- after 9 months of wearing a new generation contact lens in one eye, most unusual crystalline deposit formed at the periphery and mid-periphery of the lens whereas the other eye, wearing an older, conventional contact lens, underwent no such complication. The pt was using boston advance solutions, and the new lens. No such phenomenon has occurred to other pts wearing the onsi-56, but all of them are using unique ph as their cleaning and disinfecting solution.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1037608 |
| MDR Report Key | 662179 |
| Date Received | 2005-11-27 |
| Date of Report | 2005-11-27 |
| Date of Event | 2005-09-22 |
| Date Added to Maude | 2006-01-12 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | ONSI 56 GAS PERMEABLE CONTACT LENS |
| Generic Name | RGP CONTACT LENS |
| Product Code | HPX |
| Date Received | 2005-11-27 |
| Model Number | ONSI 56 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 651589 |
| Manufacturer | LAGADO CORPORATION |
| Manufacturer Address | * * CA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-11-27 |