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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC. OPTI-FREE PUREMOIST WITH HYDRAGLYDE; ACCESSORIES, SOFT LENS PRODUCTS

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ALCON RESEARCH, LLC. OPTI-FREE PUREMOIST WITH HYDRAGLYDE; ACCESSORIES, SOFT LENS PRODUCTS Back to Search Results
Lot Number 118WY
Device Problems Device Emits Odor (1425); Product Quality Problem (1506)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/20/2023
Event Type  malfunction  
Event Description
Moldy smell from contact solution.Opti-free puremoist with hydraglyde.Purchased at costco within the last 2 months.Box included 2 x 14 fl oz bottles.Both bottles smell moldy.Lot:118wy, exp:2025-07-31.
 
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Brand Name
OPTI-FREE PUREMOIST WITH HYDRAGLYDE
Type of Device
ACCESSORIES, SOFT LENS PRODUCTS
Manufacturer (Section D)
ALCON RESEARCH, LLC.
MDR Report Key16247112
MDR Text Key308262336
Report NumberMW5114513
Device Sequence Number1
Product Code LPN
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/23/2023
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received01/25/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Lot Number118WY
Was Device Available for Evaluation? Yes
Patient Sequence Number1
Patient Age46 YR
Patient SexFemale
Patient Weight81 KG
Patient EthnicityNon Hispanic
Patient RaceWhite
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