MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-24 for POLYCARBONATE EYEGLASS LENSES POLY FTHRWTS CLASSIC PREM AR SINGLE VISION PREMIUM VO 3940 manufactured by Luxottica Group Spa.
[115137358]
Purchased polycarbonate eyeglass lenses from (b)(6). The lens cracked after six months. This is the second pair this has happened to (which necessitated the purchase of these lenses. ). (b)(6) does not stand behind their product unless you pay for an additional insurance product. Purchasing polycarbonate is done for safety. Their product is defective.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078609 |
| MDR Report Key | 7718218 |
| Date Received | 2018-07-24 |
| Date of Report | 2018-07-23 |
| Date of Event | 2018-07-23 |
| Date Added to Maude | 2018-07-25 |
| 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 | UNKNOWN |
| 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 | POLYCARBONATE EYEGLASS LENSES POLY FTHRWTS CLASSIC PREM AR SINGLE VISION PREMIUM |
| Generic Name | LENS, SPECTACLE, NON-CUSTOM |
| Product Code | HQG |
| Date Received | 2018-07-24 |
| Model Number | VO 3940 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LUXOTTICA GROUP SPA |
| Brand Name | POLYCARBONATE EYEGLASS LENSES POLY FTHRWTS CLASSIC PREM AR SINGLE VISION PREMIUM |
| Generic Name | LENS, SPECTACLE, NON-CUSTOM |
| Product Code | HQG |
| Date Received | 2018-07-24 |
| Model Number | VO 3940 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | LUXOTTICA GROUP SPA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-24 |