MAUDE Adverse Event Report: CLEAR CARE

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Irritation (1941); Pain (1994); Swelling (2091); Discomfort (2330)

Event Date 06/01/2016

Event Type  Injury  

Event Description

I use contact lenses.My contacts were dry, so i removed one lens, and i reached for my husband's lens solution (was not in the box).I squeezed the contact solution on my contact ("clear care" contact lens solution, no rub, safe for soft lenses, etc.) i put the contact in my eye.The pain was indescribable.I could not get all the lens out-the solution melted and fragmented the contact.My eye was red, swollen and raw for 2 full days, and my eye stayed sore and ached for weeks.The clear care contact lens solution "melted" or fused part of the contact to my eyeball.It has now been just over 1 year, and i noticed yesterday that some on-going irritation is due to a piece of the contact still being fused to my eye ball.Because of the clear care solution, the fragment of contact lens is melted like glue fragments to my eyeball still after a year.I cannot remove the piece of contact because it is literally fused/melted/glued on.I have not seen a doctor because i have no insurance to cover what would likely be an expensive bill.My eye ball stopped hurting and aching after a few weeks, but i have had discomfort and irritation since this incident occurred a year ago.Clear care contact solution needs to boldly warn everyone that it can burn/melt a contact to the eye ball and cause the most extreme and indescribable pain if the solution gets in the eye.They need to tell consumers that the aftermath can literally last more than a year.

• Brand Name: CLEAR CARE
• Type of Device: CLEAR CARE
• MDR Report Key: 6705715
• MDR Text Key: 79981654
• Report Number: MW5070903
• 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: 07/08/2017

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: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/08/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR