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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRK LASER MACHINE FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION

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PRK LASER MACHINE FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Dry Eye(s) (1814); Pain (1994); Visual Disturbances (2140)
Event Date 07/01/2021
Event Type  Injury  
Event Description
Had prk lasik surgery done and it has ruined my eyes. Severe complications. This effects my ability to work and do normal day to day activities. I have a severe case of photophobia followed by ocular pain. Chronic dry eyes. (b)(6) eye center. Fda safety report id # (b)(4).
 
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Brand NamePRK LASER MACHINE
Type of DeviceFEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION
MDR Report Key12689348
MDR Text Key278569643
Report NumberMW5104923
Device Sequence Number1
Product Code OTL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 10/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? 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: 10/22/2021 Patient Sequence Number: 1
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