MAUDE Adverse Event Report: ALCON LABORATORIES, INC. CLEAR CARE; LENS SOLUTION

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 01/01/2016

Event Type  Other  

Event Description

I bought clear care contact solution thinking it was a multi-purpose solution that cleaned and disinfected.My usual brand (b)(6) was not available when i got home i open the box and put them on my sink.The next morning i open a bottle without reading because it was by the other contact lens solution and poured it in my right eye.Immediately my eye stung and was on fire.So far only temporary injury.When and how was error discovered: i have not been to the doctor yet but i might lose my eyesight in my right eye.It is swollen almost shut.This is my better eye of the two.Reporter's recommendations: i believe that this should only be prescribed and this should not be in the same area of the other multi use formals for contact lens solution.(b)(6).

• Brand Name: CLEAR CARE
• Type of Device: LENS SOLUTION
• Manufacturer (Section D): ALCON LABORATORIES, INC.
• MDR Report Key: 5913401
• MDR Text Key: 53671277
• Report Number: MW5064428
• Device Sequence Number: 0
• Product Code: LPN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 06/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2016
• Device Operator: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1