MAUDE Adverse Event Report: ALCON CLEAR CARE; CONTACT LENS SOLUTION

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Autoimmune Disorder (1732); Scarring (2061); Burning Sensation (2146)

Event Type  No Answer Provided  

Event Description

Unknowingly soaked my contact lenses in clear care contact solution several years ago and experienced extreme burning to my eyes when i tried to put my contacts in.It took several minutes to remove the lenses and i immediately washed eyes with water, until burning subsided.A year or two later, i started having entropion, primarily in my left eye, causing my eyelashes to scratch my cornea.When i went to my ophthalmologist, i had forgotten about the clear care incident and, since i had scarring under my eyelids, he suspected an autoimmune disease called ocular cicatricial pemphigoid.I was referred to another ophthalmologist, as well as a dermatologist, who both had expertise in the disease.The ophthalmologist did a biopsy on my eyelid, and the dermatologist did a biopsy on the inside of my cheek.Both were negative/inconclusive.A few months later, i went to (b)(6) to visit an ophthalmologist named dr.(b)(6) at the (b)(6).He did another biopsy, this time a large chunk of the inside of my eyelid was cut out, and again the results were negative or inconclusive.Apparently, there is no test that can definitively diagnose the disease.So i have been taking, for the past several years, a medication called dapsone, under the assumption that i have this disease.All of the doctors say that it is unlikely that my experience with clear care could have caused scarring and entropion to my eyelids.I would like to know if anyone else has had this result from the use of clear care.I don't want to continue to take this medicine if it is possible that i do not have an autoimmune disease, rather, simply experienced scarring on my eyelids from the clear care.

• Brand Name: CLEAR CARE
• Type of Device: CONTACT LENS SOLUTION
• Manufacturer (Section D): ALCON
• MDR Report Key: 6979224
• MDR Text Key: 90520741
• Report Number: MW5072969
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• 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: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 70