BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISUMAX LASER KERATOME

    MDR report key: 8192604 · Received December 21, 2018

    Report

    Report Number
    9615030-2018-00014
    Event Type
    Injury
    Date Received
    December 21, 2018
    Date of Event
    July 4, 2018
    Report Date
    November 29, 2018
    Manufacturer
    CARL ZEISS MEDITEC AG (JENA)
    Product Code
    OTL
    PMA / PMN Number
    P150040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER REVIEWED THE ON-SITE SERVICE DOCUMENTATION WHICH CONFIRMED THAT THE DEVICE WAS WORKING WITHIN SPECIFICATION. THE INVESTIGATION HAS NOT IDENTIFIED ANY ABNORMALITY OR PRODUCT DEFICIENCY RELATED TO THE INCIDENT. THE MANUFACTURER REVIEWED THE DOCUMENT LABELLING FOR VISUMAX LASER KERATOME. THE USER MANUAL (IFU 000000-1345-518-DOKS-SM-KR-211114, P. 6-9) DESCRIBES ECTASIA AS A CONTRAINDICATION AND SIDE EFFECT THAT CAN BE ASSOCIATED WITH THE VISUMAX LASER PROCEDURE. MOREOVER THE USER MANUAL DESCRIBES HEADACHE, DRY EYE, VISUAL DISTURBANCE AS SIDE EFFECTS THAT CAN BE ASSOCIATED WITH THE VISUMAX LASER PROCEDURE. THE USER MANUAL ALSO ADVISES THE HEALTHCARE PROFESSIONAL TO PERFORM A CLINICAL EVALUATION TO IDENTIFY ANY ADDITIONAL SIDE EFFECTS FROM THE RELEVANT TECHNICAL LITERATURE AND MEDICAL ASSOCIATIONS.

    Description of Event or Problem · 1

    ON 11/29/2018, CARL ZEISS MEDITEC (CZM) RECEIVED A VOLUNTARY REPORT (MW5081613) FROM THE FDA SUBMITTED BY A PATIENT WHO UNDERWENT A RELEX SMILE SURGERY ON (B)(6) 2018 WITH THE VISUMAX DEVICE AND COLLAGEN-CROSS LINKING (CXL). CXL IS A TREATMENT THAT IS PROVIDED BY A THIRD PARTY COMPANY AND IT IS NOT IN THE RESPONSIBILITY OF CZM. PER THE REPORT, THE PATIENT'S EYE SIGHT WAS NOT CORRECTED TO 1.0 AFTER THE SURGERY - THE PATIENT'S VISION ON THE LEFT EYE WAS REPORTED TO BE 0.5 WHILE THE RIGHT EYE WAS REPORTED TO BE 0.6. THE PATIENT REPORTED SEEKING OTHER DOCTORS' OPINIONS. THEY COMMUNICATED TO THE PATIENT THAT THIS IS AN IRREGULAR ASTIGMATISM WHICH CANNOT BE CORRECTED BY GLASSES. THE PATIENT REPORTED EXPERIENCING NUMEROUS SIDE EFFECTS SUCH AS HEADACHES, NAUSEA, DOUBLE VISION, BLURRY VISION, GHOSTING, GLARE, STARBURST, SHADOWS, DRY EYE, EYE BURNING, EYE PAIN, FLOATERS AND ECTASIA. TREATMENT VIDEOS AND PATIENT INFORMATION WERE REQUESTED FROM THE EYE CLINIC IN (B)(6), BUT DUE TO LOCAL REGULATIONS, IT HAS NOT BEEN PROVIDED. THE PATIENT'S PRE-OPERATIVE CONDITIONS ARE CURRENTLY UNKNOWN AND STABLE POST-OPERATIVE INFORMATION WERE NOT PROVIDED FOR EACH EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031018 VISUMAX LASER KERATOME FEMTOSECOND LASER SYSTEM FOR REFRACTIVE CORRECTION OTL CARL ZEISS MEDITEC AG (JENA) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other