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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFT CONTACT LENS

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SOFT CONTACT LENS Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Acanthameba Keratitis (1945); Ulcer (2274)
Event Date 09/15/2018
Event Type  Injury  
Event Description
Fungal keratitis, left eye. History of soft contact lens wear with poor hygiene - sleeping in contact lenses. Growing unusual organism: bipolaris! woke up with severe fungal ulcer.
 
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Brand NameSOFT CONTACT LENS
Type of DeviceSOFT CONTACT LENS
MDR Report Key7960599
MDR Text Key124885241
Report NumberMW5080531
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 10/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/11/2018
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?
Type of Device Usage

Patient Treatment Data
Date Received: 10/11/2018 Patient Sequence Number: 1
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