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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARL ZEISS MEDITEC AG (JENA) RELEX SMILE REFRACTIVE SURGERY FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION

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CARL ZEISS MEDITEC AG (JENA) RELEX SMILE REFRACTIVE SURGERY FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Dry Eye(s) (1814); Keratitis (1944); Visual Impairment (2138); Neuralgia (4413); Increased Sensitivity (4538)
Event Date 07/30/2019
Event Type  Injury  
Event Description
Relex smile refractive surgery to both eyes. Two (2) year post surgery symptoms: severe corneal inflammation, corneal neuralgia, aberrant corneal nerve growth, recurrent superficial punctate keratitis, aqueous deficient dry eyes 2mm schirmer), meibomian gland dysfunction, filamentary keratitis. Corneal hyperaesthesia, evaporative dry eyes, photophobia. Loss of best corrected vision. Fda safety report id # (b)(4).
 
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Brand NameRELEX SMILE REFRACTIVE SURGERY
Type of DeviceFEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION
Manufacturer (Section D)
CARL ZEISS MEDITEC AG (JENA)
MDR Report Key12589923
MDR Text Key275431718
Report NumberMW5104442
Device Sequence Number1
Product Code OTL
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 10/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
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: 10/06/2021 Patient Sequence Number: 1
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