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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON LABORATORIES, INC. LASIK MACHINE; EXCIMER LASER SYSTEM

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ALCON LABORATORIES, INC. LASIK MACHINE; EXCIMER LASER SYSTEM Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Visual Impairment (2138); Discomfort (2330)
Event Date 01/14/2016
Event Type  Injury  
Event Description
I had lasik performed; i was told lasik was right for me and i was a good candidate.Turns out i have very large pupils and was lied to.I have horrible night vision now and even after being fit with specialty contacts (which is still ongoing) by a specialist, i am still have some distorted vision at night.My eyes are also not as comfortable as they were pre lasik.Please have lasik pulled off the market.Fda safety report id # (b)(4).
 
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Brand Name
LASIK MACHINE
Type of Device
EXCIMER LASER SYSTEM
Manufacturer (Section D)
ALCON LABORATORIES, INC.
MDR Report Key11412619
MDR Text Key235038598
Report NumberMW5099777
Device Sequence Number1
Product Code LZS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/01/2021
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 Health Professional
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/03/2021
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age32 YR
Patient Weight77
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