MAUDE Adverse Event Report: ALCON RESEARCH, LTD. CLEAR CARE 12 OZ; ACCESSORIES, SOFT LENS PRODUCTS

Device Problem Device Markings/Labelling Problem (2911)

Patient Problems Erythema (1840); Pain (1994); Increased Sensitivity (2065); Burning Sensation (2146)

Event Date 01/01/2018

Event Type  No Answer Provided  

Event Description

Clear care 12 oz bottle- mistaken for my daughter's lens solution.Final outcome: temporary harm/injury; final outcome comment: 2nd ¿ eye still red, burning and light sensitive.I forgot my lens solution when i went to my daughter¿s.When i saw what i thought was the bottle, i filled my lens case to store my contacts overnight.When i put my lens in the next morning, i got an instant burning- like jalapeno juice in the eye.It immediately turned red.I thought i must be having a reaction to her lens solution.Got my contact lens out and told her.She informed me i must have used the clear care (12 oz) and she has done that before and has pain and redness for 24 hours.I had to wear my glasses all day and the pain, burning and redness never went away.I was also very light sensitive after this episode.(even though i had rx sunglasses on.) make the packaging less like contact lens solution; large warning on front of bottle with a big red circle with a line going through an eye.Make the bottle bright red or yellow, so when in the same vicinity of regular lens solution, doesn't get mistaken.Remember the folks using this stuff are vision impaired.I used to use this type of system and it was in tablet form not solution.That would also solve the problem as no one puts a tablet in their eye.(b)(6).

• Brand Name: CLEAR CARE 12 OZ
• Type of Device: ACCESSORIES, SOFT LENS PRODUCTS
• Manufacturer (Section D): ALCON RESEARCH, LTD.
• MDR Report Key: 8190056
• MDR Text Key: 131527803
• Report Number: MW5082424
• 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
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• 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