MAUDE Adverse Event Report: ALCON LABORATORIES, INC. CLEAR CARE CONTACT SOLUTION; ACCESSORIES, SOFT LENS PRODUCTS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Pain (1994); Swelling (2091); Burning Sensation (2146); Complaint, Ill-Defined (2331)

Event Type  No Answer Provided  

Event Description

Used alcon clear care contact solution.It was on sale on a shelf next to the normal contact solution.I woke up the next morning after soaking my contacts all night and experienced unbelievable pain.I dropped to my knees and screamed in pain trying to get the contact out.Worst burning and eye pain i've ever had in my life.My eye turned completely red and swollen and still hurts 48 hours later.Patient counseling provided: unk.Patient age: adult (18-64 years).(b)(6).

• Brand Name: CLEAR CARE CONTACT SOLUTION
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON LABORATORIES, INC.
• MDR Report Key: 6950933
• MDR Text Key: 89625469
• Report Number: MW5072753
• Device Sequence Number: 1
• Product Code: LPN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1