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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS LASIK WAVEFRONT

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ABBOTT MEDICAL OPTICS LASIK WAVEFRONT Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Dry Eye(s) (1814); Visual Impairment (2138)
Event Type  Injury  
Event Description
I got lasik a few years ago and now have worsened dry eyes, and my night vision is significantly impaired.I don't experience severe halos, but enough to make a difference.The worst however is lowered perception of shades of gray/darkness, which makes it more difficult to see clearly in low light conditions.
 
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Brand Name
LASIK WAVEFRONT
Type of Device
LASIK WAVEFRONT
Manufacturer (Section D)
ABBOTT MEDICAL OPTICS
MDR Report Key3542249
MDR Text Key4126303
Report NumberMW5033610
Device Sequence Number1
Product Code LZS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/23/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/24/2013
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Patient Sequence Number1
Patient Age31 YR
Patient Weight55
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