MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-02 for EYEGLASSES manufactured by Unk.
[99095332]
I ordered two sets of glasses from (b)(4). There apparently was no quality control of the glasses. The image through both was badly distorted. I am concerned about (b)(4) distributing glasses with no quality control, which could hurt people's sight and maybe cause falls. I have photos taken through the glasses and without the glasses that prove the distortion. Zenni optical.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075064 |
| MDR Report Key | 7241006 |
| Date Received | 2018-02-02 |
| Date of Report | 2018-02-01 |
| Date of Event | 2018-02-01 |
| Date Added to Maude | 2018-02-05 |
| 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 | EYEGLASSES |
| Generic Name | LENS, PRESCRIPTION EYE GLASSES |
| Product Code | HQG |
| Date Received | 2018-02-02 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-02 |