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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON LABORATORIES, INC. CLEAR CARE PLUS; ACCESSORIES SOFT LENS PRODUCTS
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ALCON LABORATORIES, INC. CLEAR CARE PLUS; ACCESSORIES SOFT LENS PRODUCTS Back to Search Results
Lot Number 292077F
Device Problem Material Integrity Problem (2978)
Patient Problems Corneal Edema (1791); Blurred Vision (2137); Visual Disturbances (2140); Reaction (2414); Patient Problem/Medical Problem (2688)
Event Date 09/02/2018
Event Type  Injury  
Event Description
I have hybrid contacts.I have been using clear care lens cleaning for 10 years.I switched to clear care plus in early (b)(6).A bit over a week after switching, my vision became cloudy in my left eye.Within a day, i couldn't see anything through that eye, even when the lens was out.I visited my optometrist who diagnosed serious corneal edema with sores on my cornea.I was prescribed prednisone drops.The next day, my right eye started becoming foggy.This time i immediately removed my lens.The condition stopped worsening.The only change was using clear care plus instead of clear care.My left eye is still cloudy and may be permanently damaged.Damaged vision.Frequency: at bedtime.Overnight solution for contact lens cleaning.Date the person started taking or using the product: (b)(6) 2018; date the person stopped taking or using the product: (b)(6) 2018.
 
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Brand Name
CLEAR CARE PLUS
Type of Device
ACCESSORIES SOFT LENS PRODUCTS
Manufacturer (Section D)
ALCON LABORATORIES, INC.
MDR Report Key7872446
MDR Text Key120301385
Report NumberMW5079765
Device Sequence Number1
Product Code LPN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date01/01/2020
Device Lot Number292077F
Was Device Available for Evaluation? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age73 YR
Patient Weight108
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