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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK EXCIMER LASER SYSTEM

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LASIK EXCIMER LASER SYSTEM Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dry Eye(s) (1814); Pain (1994); Visual Impairment (2138); Suicidal Ideation (4429)
Event Date 07/27/2020
Event Type  Injury  
Event Description
Dry eye and night vision loss after lasik surgery. The dry eye pain is debilitating, it has developed into depression, and suicidal thoughts. Fda safety report id# (b)(4).
 
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Brand NameLASIK
Type of DeviceEXCIMER LASER SYSTEM
MDR Report Key10927172
MDR Text Key218922898
Report NumberMW5098143
Device Sequence Number1
Product Code NAY
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
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: 12/01/2020 Patient Sequence Number: 1
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