MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-06 for 1.57 PHOTOCHROMIC SINGLE VISION-AMBER ZENNI OPTICAL LENS manufactured by Zenni Optical.
[66864172]
I purchased uv blocking photochromic glasses from zenni optical. I tested them after using them for a year, and they don't block uv light. I am concerned about the damage done to my eyes. Retailed: (b)(6). Purchase date: (b)(6) 2015. The product was damaged before the incident: no. The product was modified before the incident: no. Zenni optical frames and lenses. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5067692 |
| MDR Report Key | 6307403 |
| Date Received | 2017-02-06 |
| Date of Report | 2017-01-21 |
| Date of Event | 2015-12-27 |
| Date Added to Maude | 2017-02-07 |
| 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 FAMILY MEMBER OR FRIEND |
| 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 | 1.57 PHOTOCHROMIC SINGLE VISION-AMBER ZENNI OPTICAL LENS |
| Generic Name | ZENNI OPTICAL LENS |
| Product Code | HQY |
| Date Received | 2017-02-06 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZENNI OPTICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-06 |