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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC. OPTI-FREE PURE MOIST; ACCESSORIES, SOFT LENS PRODUCTS

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ALCON RESEARCH, LLC. OPTI-FREE PURE MOIST; ACCESSORIES, SOFT LENS PRODUCTS Back to Search Results
Lot Number 10NM3
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Contact Dermatitis (4546)
Event Date 10/20/2021
Event Type  Injury  
Event Description
After alcon replaced opti-free replenish with pure moist contact lens solution, i began experiencing severe dermatitis around both eyes that took months to diagnose and is only now beginning to resolve, but i can no longer use any contact lens solution.
 
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Brand Name
OPTI-FREE PURE MOIST
Type of Device
ACCESSORIES, SOFT LENS PRODUCTS
Manufacturer (Section D)
ALCON RESEARCH, LLC.
MDR Report Key14266922
MDR Text Key290658435
Report NumberMW5109470
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 04/29/2022
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 Expiration Date05/31/2024
Device Lot Number10NM3
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/02/2022
Patient Sequence Number1
Patient Age42 YR
Patient SexFemale
Patient EthnicityNon Hispanic
Patient RaceWhite
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