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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR

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CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Device Problem Expiration Date Error (2528)
Patient Problem Insufficient Information (4580)
Event Description
Patient was sold contacts with an expired prescription. Fda safety report id# (b)(4).
 
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Brand NameCONTACT LENSES
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
MDR Report Key12829933
MDR Text Key281015216
Report NumberMW5105398
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes

Patient Treatment Data
Date Received: 11/16/2021 Patient Sequence Number: 1
Treatment
BIOFINITY TORIC: (B)(6) 2019-(B)(6) 2020
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