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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LASIK SURGERY; EXCIMER LASER SYSTEM

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LASIK SURGERY; EXCIMER LASER SYSTEM Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Dry Eye(s) (1814); Vitreous Floaters (1866); Visual Impairment (2138); Visual Disturbances (2140); Depression (2361)
Event Date 09/18/2020
Event Type  Injury  
Event Description
My husband had lasik surgery with dr (b)(6) from (b)(6).He has severe dry eyes, vision change, light sensitivity, floaters, no contrast in his vision.Plus he is severely depressed from it.Has to have professional psychological help.Fda safety report id# (b)(4).
 
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Brand Name
LASIK SURGERY
Type of Device
EXCIMER LASER SYSTEM
MDR Report Key11731672
MDR Text Key247716160
Report NumberMW5100999
Device Sequence Number1
Product Code LZS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 04/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/26/2021
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Disability;
Patient Age45 YR
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