MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-10 for CLEAR CARE PLUS WITH HYDRAGLYDE manufactured by Alcon Research, Llc.
[183290664]
Not paying attention when putting contact lenses in eye. Needed to rinse one of the lenses and grabbed the bottle of h2o2 solution instead of saline. Which after years of wearing, is the same shape and size as the saline solution. Rinsed and put the contact in my eye. "yow", rinsed for 10 to 15 mins with running water. The similar bottle size is what tripped me up. I know, red cap. But i already mention my attention at the time. Quantity: 12 ounce(s). Frequency: bed time. Date first started taking or using the product: (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093663 |
| MDR Report Key | 9818184 |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-08 |
| Date of Event | 2020-03-08 |
| Date Added to Maude | 2020-03-11 |
| 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 PLUS WITH HYDRAGLYDE |
| Generic Name | ACCESSORIES, SOFT LENS PRODUCTS |
| Product Code | LPN |
| Date Received | 2020-03-10 |
| Lot Number | 314976F |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LLC |
| Brand Name | 3% |
| Product Code | --- |
| Date Received | 2020-03-10 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-10 |