MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-31 for GAS PERMEABLE CONTACT LENS manufactured by Unk.
[132272238]
My optometrist, dr (b)(6), has been ordering my gas-permeable contact lenses from international contact lens lab in (b)(6) for five years. Every time i get new lenses, the vision is obscured by either glue or fingerprints on the lenses. My doctor cleans and polishes them, and i clean them meticulously, and we can't get clean lenses. So we order more, then the same thing, and then eventually i will get a pair that i can see out of. Meanwhile, i can't see out of... Name of the company that makes the medical device: international contact lens lab. (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082748 |
| MDR Report Key | 8208722 |
| Date Received | 2018-12-31 |
| Date of Report | 2018-12-19 |
| Date of Event | 2018-12-10 |
| Date Added to Maude | 2019-01-02 |
| 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 | GAS PERMEABLE CONTACT LENS |
| Generic Name | PRODUCTS, CONTACT LENS CARE, RIGID GAS PERMEABLE |
| Product Code | MRC |
| Date Received | 2018-12-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| 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 | 2018-12-31 |