MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-21 for PRESCRIPTION GLASSES manufactured by Zenni Optical Inc..
[70711305]
Have purchased multiple sets of prescription glasses from (b)(6) an online glasses retailer. The glasses never seem to have the right prescription for me, as i would have difficulty seeing, eye pain, and frequent headaches. I assumed that i was adjusting to the new prescription. After discussing with my doctor we decided to have the last two sets (multiple pairs were ordered in 2014 and 2016) evaluated for actual prescription reading. The pairs of glasses ordered together had matching prescription readings, however both orders significantly differed from my doctor's prescription for my glasses. The retailer was contacted, but said i only had a 30 day window for returns. With glasses, i should have returned them within the retailer policy window, but i don't want other consumers to suffer the consequences i have dealt with this past two years. I'm not interested in getting money back. I'm upset that as a patient there is no easy way to show the doctors prescribed orders were accurately filled with my prescription glasses.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068583 |
| MDR Report Key | 6427256 |
| Date Received | 2017-03-21 |
| Date of Report | 2017-03-21 |
| Date of Event | 2017-03-21 |
| Date Added to Maude | 2017-03-23 |
| 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 | 3 |
| Brand Name | PRESCRIPTION GLASSES |
| Generic Name | LENS, SPECTACLE, NON-CUSTOMER (PRESCRIPTION) |
| Product Code | NJH |
| Date Received | 2017-03-21 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZENNI OPTICAL INC. |
| Brand Name | PRESCRIPTION GLASSES |
| Generic Name | LENS, SPECTACLE, NON-CUSTOMER (PRESCRIPTION) |
| Product Code | NJH |
| Date Received | 2017-03-21 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | ZENNI OPTICAL INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-21 |