MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-02-11 for CLEANING AND DISINFECTING LENS CARE SYSTEM (TARGET BRAND) manufactured by Target.
[18363050]
When used as directed, the target brand (up and up) cleaning and disinfecting lens care system (3% hydrogen peroxide solution), my eyes sting when inserting contact lenses after following doctor's advice and the product directions. I filled the lens container to the line with solution, closed the cap (but not over-tightening), allowed to set overnight (8:00 pm to 6:30 am), and rinsed the lenses with saline solution prior to inserting the lenses. Then my eyes stung so bad i had to immediately remove the lenses. My eyes were very red afterward. I have tried the ciba vision brand solution previously and with no problems. This also occurred a few months ago with the same brand of solution. I returned it to the store and explained what happened. Diagnosis or reason for use: disinfection of contact lenses (johnson and johnson oasys). Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5034549 |
| MDR Report Key | 3636674 |
| Date Received | 2014-02-11 |
| Date of Report | 2013-10-19 |
| Date of Event | 2013-10-19 |
| Date Added to Maude | 2014-02-21 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLEANING AND DISINFECTING LENS CARE SYSTEM (TARGET BRAND) |
| Generic Name | CLEANING AND DISINFECTING LENS CARE SYSTEM (TARGET BRAND) |
| Product Code | LPN |
| Date Received | 2014-02-11 |
| Device Availability | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | TARGET |
| Brand Name | CLEANING AND DISINFECTING LENS CARE SYSTEM (TARGET BRAND) |
| Generic Name | CLEANING AND DISINFECTING LENS CARE SYSTEM (TARGET BRAND) |
| Product Code | HPX |
| Date Received | 2014-02-11 |
| Device Expiration Date | 2016-07-01 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TARGET |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-11 |