MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-10-14 for MANY manufactured by Many.
[20272641]
There are no warnings on cheap nonprescription sunglasses that say they do not stop uv radiation which is damaging to they eyes. I thought that since the fda had standards for sunglasses that any sunglasses i would buy would provide uv protection. Instead of protecting the eyes, some brands of sunglasses damage the eyes because they cause pupils to open and admit more uv. Glasses that do not protect the eyes against uv should have a statement on their label saying that. Diagnosis or reason for use: protection of eyes from effects of uv from sun.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5038644 |
| MDR Report Key | 4189192 |
| Date Received | 2014-10-14 |
| Date of Report | 2014-10-14 |
| Date of Event | 2014-10-14 |
| Date Added to Maude | 2014-10-22 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MANY |
| Generic Name | SUNGLASSES |
| Product Code | HQY |
| Date Received | 2014-10-14 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MANY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-14 |