MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-03-01 for ROSE K * manufactured by Blanchard Contact Lens, Boston, Bausch And Lomb.
[477687]
Rptr's son has keratconus. He has been getting rose k lenses -contact- for this from a local eye clinic. The problem is that the lenses keep breaking in his eye and this is an untenable situation for him to deal with. These lenses help him very little but it is better than nothing. The scary thing is that he could very well get damaged eyes from this material and rptr fears that he would go blind. When one breaks, the eye center is willing to sell him another, but it takes him a long time to get that kind of money to get another. They have never tried to warranty this and after 6 pairs in one year, rptr feels the material is defective or not up to standards.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1038180 |
| MDR Report Key | 691508 |
| Date Received | 2006-03-01 |
| Date of Report | 2006-03-01 |
| Date Added to Maude | 2006-03-27 |
| 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 | PATIENT |
| 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 | ROSE K |
| Generic Name | CONTACT LENSES |
| Product Code | HPX |
| Date Received | 2006-03-01 |
| Returned To Mfg | 2006-02-28 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 680645 |
| Manufacturer | BLANCHARD CONTACT LENS, BOSTON, BAUSCH AND LOMB |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-03-01 |