MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-01-30 for UNIQUE PH SOLUTION manufactured by Menicon.
[15156688]
For the first time i used menicon unique ph solution for my contact lenses. By the end of the day my eyes were irritated, and when i took my lenses out. I noticed that both lenses has smudges in the center. Cleaning them did not remove the smudges. The smudges are irritating to my eyes and blur my vision when i put the contact on. I can no longer use these lenses.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5034163 |
| MDR Report Key | 3607564 |
| Date Received | 2014-01-30 |
| Date of Report | 2014-01-30 |
| Date of Event | 2013-11-14 |
| Date Added to Maude | 2014-02-06 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNIQUE PH SOLUTION |
| Generic Name | UNIQUE PH SOLUTION |
| Product Code | MRC |
| Date Received | 2014-01-30 |
| Lot Number | 195625F |
| Device Expiration Date | 2014-05-01 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MENICON |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-01-30 |