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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARL ZEISS MEDITEC INC. ZEISS LASER

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CARL ZEISS MEDITEC INC. ZEISS LASER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dry Eye(s) (1814); Vitreous Floaters (1866)
Event Date 02/04/2018
Event Type  Injury  
Event Description
I went through relex smile lasik at (b)(6) hospital (b)(6). I thought i would save my expenses and doctor said i have perfect eyes, but after 14 days i suffered from irregular cornea and floaters in my both eyes and doctor never cared. Told me it's my mind, i see ghost images at night, now very bad and have a lot of dryness trying to recover from yoga but i wasn't a perfect candidate. He did this surgery and harmed my healthy eyes, never told me about side effects.
 
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Brand NameZEISS LASER
Type of DeviceZEISS LASER
Manufacturer (Section D)
CARL ZEISS MEDITEC INC.
MDR Report Key7889329
MDR Text Key120979982
Report NumberMW5079886
Device Sequence Number0
Product Code OTL
Combination Product (y/n)N
Reporter Country CodeIN
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 Received09/18/2018
Is this an Adverse Event Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 09/18/2018 Patient Sequence Number: 1
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