MAUDE Adverse Event Report: NOVARTIS CLEAR CARE

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Swelling (2091); Burning Sensation (2146)

Event Date 04/12/2014

Event Type  Injury  

Event Description

I bought clear care solution for cleaning lenses.I used it like regular saline lens cleaning product, rinsed my lenses and put them on.Caused extreme burning in the eyes like i had acid in them.They got red and swollen for a couple of days.Later saw the instructions that were very different from regular lens solution.Have been wearing lenses for 15 years so didn't feel the need to read instructions carefully.Product needs to be labelled and named differently and sold in a separate area from regular lens solutions.Horrible experience.Returned it the day after.Hope my eyes don't feel any permanent damage because of this.(b)(6).

• Brand Name: CLEAR CARE
• Type of Device: CLEAR CARE
• Manufacturer (Section D): NOVARTIS
• MDR Report Key: 3761673
• MDR Text Key: 19972208
• Report Number: MW5035706
• 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: Patient
• Type of Report: Initial
• Report Date: 04/15/2014

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: Lay User/Patient
• Device Expiration Date: 06/30/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/16/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 33 YR
• Patient Weight: 50