MAUDE Adverse Event Report: ALCON CLEAR CARE PLUS; CLEANING AND DISINFECTING SOLUTION

Lot Number 258863F

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Corneal Abrasion (1789); Headache (1880); Nausea (1970); Pain (1994); Blurred Vision (2137)

Event Date 07/01/2017

Event Type  Injury  

Event Description

I have been using clear care hydrogen peroxide contact lens solution for over six years, and have never had an issue.A few days ago i bought clear care plus hydraglyde instead, as it is marketed as a more moisturizing alternative for soft contact lens wearers.I immediately noticed that the contacts caused me to see a hazy fog everywhere i looked, and created a rainbow halo over lights.If this were my only issue with the product, i would not be reporting it.However, after wearing my contacts after cleaning them in this solution for three days, i began to experience pain and blurry vision, and took the contacts out.This ensured what can only be described as 36 hours of absolute hell, as my eyes began to feel as if someone were rubbing sandpaper against, or sticking needles into them.My eyes watered uncontrollably and i could not even open them enough to call a family member for help for several hours.This pain was accompanied by a severe headache and nausea, both additional symptoms of corneal abrasion.I called an ophthalmologist and was told my corneas had been scratched, and to keep my eyes closed for a day or so and use artificial tears, which i did.After a day i went in to the urgent eye care center at (b)(6) hospital in (b)(6), and was told both of my eyes had been severely scratched/damaged by my contact lenses.This solution is the only variable that changed, and i was horrified to read on (b)(6) reviews that i am far from the first consumer to have experienced these adverse effects.This is a highly dangerous product that has been on the market for years, and it shocks and saddens me that after so many consumers have come forward with similar stories it still remains on store shelves.I experienced some of the greatest physical pain of my life these last two days, and still need to administer antibiotic drops and ointment, and go without contacts, for the coming week.This product at the very least needs to be seriously investigated by the fda, and, i strongly believe, be recalled completely.

• Brand Name: CLEAR CARE PLUS
• Type of Device: CLEANING AND DISINFECTING SOLUTION
• Manufacturer (Section D): ALCON
• MDR Report Key: 6689033
• MDR Text Key: 79269073
• Report Number: MW5070808
• 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: 07/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/01/2018
• Device Lot Number: 258863F
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 19 YR
• Patient Weight: 72