MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-13 for CLEAR EYES CONTACT LENS MULTI-ACTION RELIEF LUBRICATING EYE DROPS manufactured by Prestige Brands Co Meditech Products, Inc..
[179786005]
I put 2 drops of clear eyes contact lens multi-action relief drops in each eye. Within less than 1 min i had a red irritated streak like a burn mark down my left cheek where it had blinked out from the outside corner of my eye, and the same streak along the right side of my nose from the drops being blinked out of the inner corner of the right eye. I didn't have any products on my face (moisturizer etc). The marks didn't hurt but were very red. Reason for use: dry, irritated eyes.
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW5092999 |
MDR Report Key | 9711361 |
Date Received | 2020-02-13 |
Date of Event | 2020-02-11 |
Date Added to Maude | 2020-02-14 |
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 EYES CONTACT LENS MULTI-ACTION RELIEF LUBRICATING EYE DROPS |
Generic Name | ACCESSORIES, SOFT LENS PRODUCTS |
Product Code | LPN |
Date Received | 2020-02-13 |
Lot Number | XC683 |
Device Availability | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | PRESTIGE BRANDS CO MEDITECH PRODUCTS, INC. |
Product Code | --- |
Date Received | 2020-02-13 |
Device Sequence No | 101 |
Device Event Key | 0 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-02-13 |