MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-18 for CLEAR CARE manufactured by Alcon Research, Llc.
[184323286]
This product should not be in aisles with other normal contact solutions. Rinsed my contact lense in clear care contact lense solution and experienced burning, stinging and eye redness. It burned so bad i couldn't take the contact out. Did the problem stop after the person reduced or stopped using the product? No. Frequency: daily. How was it taken or used: ophthalmic. Reason for use: to clean contacts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093833 |
| MDR Report Key | 9853254 |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-03-16 |
| Date Added to Maude | 2020-03-19 |
| 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 | 3 |
| Brand Name | CLEAR CARE |
| Generic Name | ACCESSORIES, SOFT LENS PRODUCTS |
| Product Code | LPN |
| Date Received | 2020-03-18 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-18 |