MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-24 for RIGID GAS PERMEABLE CONTACTS manufactured by Art Optical Contact Lens.
[176665767]
New rigid gas permeable lens right contact marking vanished, i was told i had to redo it with a sharpie myself, i did, twice and it vanishes. Apparently, it could be tattooed and inked permanently (as all my previous pairs of 45 years of wearing them have been). I am required to pay (b)(6) to ship and cover the cost. These cost me (b)(6) out of pocket and my expectation is they last for years and are not defective. I would like the vendor, art optical to remedy the situation and cover the cost. Neither my eye doctor or art optical will help. I called (b)(6) to complain and they said they could not talk to me directly. Please advise? Thanks for your assistance. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092506 |
| MDR Report Key | 9632236 |
| Date Received | 2020-01-24 |
| Date of Report | 2020-01-22 |
| Date of Event | 2020-01-20 |
| Date Added to Maude | 2020-01-27 |
| 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 | RIGID GAS PERMEABLE CONTACTS |
| Generic Name | LENS, CONTACT (RIGID GAS PERMEABLE) |
| Product Code | MWL |
| Date Received | 2020-01-24 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ART OPTICAL CONTACT LENS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-24 |