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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG SMILE; FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION
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CARL ZEISS MEDITEC AG SMILE; FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Dry Eye(s) (1814); Visual Impairment (2138); Visual Disturbances (2140); Halo (2227)
Event Date 02/15/2018
Event Type  Injury  
Event Description
I had smile surgery for both eyes on (b)(6) 2018 by dr (b)(6) at (b)(6) ctr in (b)(6).He told me i had no risks at all and will see well right after surgery.Now i have irregular astigmatism.I see glare, halos and starbursts from light sources during the day and night.I cannot drive in dark roads at night anymore.I have severe dryness in my eyes.Upon consulting a third party i came to know that he had treated an optical zone smaller than my scotopic pupil size.He hadn't even measured my pupil sizes.After surgery, he laughed at me when i told him my symptoms and denied his mistake.He said i have interface fluid that is causing my visual disturbances and i have higher order aberrations (hoas).He offered me lasik to fix it but i refused.When i left a review about the case on facebook, the cancelled my scheduled appts with him and he now refuses to see me.The owner of the clinic also blocked me on whatsapp.P.S: the surgeon himself wears glasses.
 
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Brand Name
SMILE
Type of Device
FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION
Manufacturer (Section D)
CARL ZEISS MEDITEC AG
MDR Report Key7885076
MDR Text Key120728417
Report NumberMW5079848
Device Sequence Number1
Product Code OTL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Disability;
Patient Age26 YR
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