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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 Patient-Device Incompatibility (2682)
Patient Problems Visual Impairment (2138); Visual Disturbances (2140); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 12/31/2021
Event Type  Injury  
Event Description
Developed central toxic keratopathy (ctk) after lasik procedure.Including severe photophobia, major hyperopic shift in eyesight, astigmatism, hazy vision, ghosting and double-vision.
 
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Brand Name
LASIK
Type of Device
EXCIMER LASER SYSTEM
MDR Report Key16157975
MDR Text Key307496752
Report NumberMW5114323
Device Sequence Number1
Product Code LZS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Unknown
Type of Report Initial
Report Date 01/10/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Other; Disability;
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