MAUDE Adverse Event Report: WAL-MART STORES, INC EQUATE HYDROGEN PEROXIDE CLEANING

Lot Number 130063

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 05/28/2015

Event Type  Injury  

Event Description

Prod: equate hydrogen peroxide cleaning and disinfecting lens bottle id (b)(4), date ex (b)(6) 2017.Prod can not be removed from soft contact lenses.Rinsed with a regular sterile solution.Prod remains on lenses, which when worn will cause the burning and stinging of the eyes.(as stated on the label).Label does not state to rinse contact lenses before using with another solution.Four hours later, my eyes still hurt.Store soft contact lenses overnight.

• Brand Name: EQUATE HYDROGEN PEROXIDE CLEANING
• Type of Device: EQUATE HYDROGEN PEROXIDE CLEANING
• Manufacturer (Section D): WAL-MART STORES, INC
• MDR Report Key: 4814909
• MDR Text Key: 21557217
• Report Number: MW5042896
• Device Sequence Number: 1
• Product Code: LPN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 09/30/2017
• Device Lot Number: 130063
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/28/2015
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 68