MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-01 for EYE GLASSES manufactured by Na.
[25337877]
I was prescribed eye glasses to correct a small degree of myopia. Unlike drug prescriptions, no warning label was included with this prescription. I later found out that the eye glasses limit peripheral vision and are known to actually worsen the symptoms of myopia over time. I have stopped wearing my eye glasses and begun to limit activities which harm my vision such as computer usage and my vision has slowly begun to return to what it once was.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5056044 |
| MDR Report Key | 5064219 |
| Date Received | 2015-09-01 |
| Date of Report | 2015-09-01 |
| Date of Event | 2009-08-21 |
| Date Added to Maude | 2015-09-09 |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EYE GLASSES |
| Generic Name | EYE GLASSES |
| Product Code | HQG |
| Date Received | 2015-09-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NA |
| Manufacturer Address | NA NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-01 |