MAUDE Adverse Event Report: CVS CVS HYDROGEN PEROXIDE CLEANING, 12 OUNCES

Lot Number 129023

Device Problem Insufficient Information (3190)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 06/02/2015

Event Type  Injury  

Event Description

After using (b)(6) hydrogen peroxide cleaning and disinfecting lens care system, lot # 129023 exp on: 08/2017, experienced unequal pupils.Had to go to er, ct scan normal.Happened again when using this product after er visit.Changed solution and symptoms resolved.Frequency: qd.Reason for use: contact lens cleanser.

• Brand Name: CVS HYDROGEN PEROXIDE CLEANING, 12 OUNCES
• Type of Device: HYDROGEN PEROXIDE CLEANING
• Manufacturer (Section D): CVS
• MDR Report Key: 4856267
• MDR Text Key: 15913384
• Report Number: MW5043127
• Device Sequence Number: 1
• Product Code: LPN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/13/2015

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: 08/01/2017
• Device Lot Number: 129023
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/13/2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 23 YR
• Patient Weight: 50