MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-03 for CLEAR CARE manufactured by Alcon.
[182316818]
Clear care contact lens solution burned my eye. When my eye was burning, i tried to flush it with more of the solution, because i never thought that a contact lens solution would burn my eye. I was unable to read the label while my eye was burning. The label on the box and the bottle is inadequate. I went to an eye hosp and had to take 2 meds. My eye is still not normal after 4. 5 days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093503 |
| MDR Report Key | 9785929 |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-01 |
| Date of Event | 2020-02-26 |
| Date Added to Maude | 2020-03-04 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLEAR CARE |
| Generic Name | ACCESSORIES, SOFT LENS PRODUCTS |
| Product Code | LPN |
| Date Received | 2020-03-03 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON |
| Product Code | --- |
| Date Received | 2020-03-03 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-03-03 |