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U.S. Department of Health and Human Services

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

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SOFT CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Keratitis (1944); Ulcer (2274)
Event Date 08/27/2021
Event Type  Injury  
Event Description
Keratitis with ulcer from sleeping in contact lenses. Fda safety report id# (b)(4).
 
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Brand NameSOFT CONTACT LENSES
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
MDR Report Key12547605
MDR Text Key274115188
Report NumberMW5104282
Device Sequence Number1
Product Code LPL
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 09/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 09/28/2021 Patient Sequence Number: 1
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