MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-05 for MAGIK CONTACT LENS CASE (LRX) GYL564 manufactured by Unk.
[79363210]
I purchased contact lenses through (b)(4) the seller is (b)(4). The item name: magik colourful contact lens box holder container case soak storage eyecare kit gyl564 (20). The 20 packs of contact lens cases did not contain indications, directions for use, warnings, country of mfr or lot number. This is against fda requirements for contact lens cases. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070836 |
| MDR Report Key | 6692790 |
| Date Received | 2017-07-05 |
| Date of Report | 2017-07-05 |
| Date of Event | 2017-07-01 |
| Date Added to Maude | 2017-07-07 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | MAGIK CONTACT LENS CASE (LRX) |
| Generic Name | CASE, CONTACT LENS |
| Product Code | LRX |
| Date Received | 2017-07-05 |
| Model Number | GYL564 |
| Device Availability | Y |
| 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 | 2017-07-05 |