MAUDE Adverse Event Report: PRESTIGE BRANDS CO MEDITECH PRODUCTS, INC. CLEAR EYES CONTACT LENS MULTI-ACTION RELIEF LUBRICATING EYE DROPS; ACCESSORIES, SOFT LENS PRODUCTS

Lot Number XC683

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Skin Irritation (2076)

Event Date 02/11/2020

Event Type  Injury  

Event Description

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.

• Brand Name: CLEAR EYES CONTACT LENS MULTI-ACTION RELIEF LUBRICATING EYE DROPS
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): PRESTIGE BRANDS CO MEDITECH PRODUCTS, INC.
• MDR Report Key: 9711361
• MDR Text Key: 179786005
• Report Number: MW5092999
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/01/2020
• Device Lot Number: XC683
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 50 YR