• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARL ZEISS RELEX SMILE LASER OPHTHALMIC

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CARL ZEISS RELEX SMILE LASER OPHTHALMIC Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Visual Impairment (2138); Visual Disturbances (2140)
Event Date 02/15/2018
Event Type  Injury  
Event Description
I had smile surgery for my eyes. The surgeon's name is dr (b)(6). He did the treatment area (optical zone) smaller than my pupil size. My vision is terrible at night and i cannot drive anymore. He lied to me about everything and told me i was risk free. He did not admit his mistake but offered lasik to enhance his mistake. He says i have interface fluid and that's why i have glare during the day as well from reflective surfaces. My vision is especially terrible at night.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRELEX SMILE
Type of DeviceLASER OPHTHALMIC
Manufacturer (Section D)
CARL ZEISS
MDR Report Key7502156
MDR Text Key108049144
Report NumberMW5077100
Device Sequence Number0
Product Code OTL
Combination Product (y/n)N
Reporter Country CodeMU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2018
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: 05/09/2018 Patient Sequence Number: 1
-
-