BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IOLMASTER

    MDR report key: 3030362 · Received March 27, 2013

    Report

    Report Number
    9615030-2013-00003
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 27, 2013
    Manufacturer
    CARL ZEISS MEDITEC AG (JENA SITE)
    Product Code
    HJO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SVC ENGINEER PERFORMED AN ON-SITE EVALUATION OF THE IOLMASTER AND FOUND THE DEVICE TO BE FUNCTIONING PROPERLY AND WITHIN SPECIFICATIONS. IT WAS REPORTED THAT THE DOCTOR CHOSE TO COMPENSATE FOR THE PREVIOUS LASIK SURGERY BY USING HIS OWN UNDISCLOSED CALCULATION METHOD RESULTING IN THE SELECTION OF A +13.0D IOL. REPRESENTATIVES OF THE MFR REVIEWED THE PT'S IOLMASTER DATA PROVIDED BY THE SITE. THE USER MANUAL STATES THAT THE USER SHOULD USE ONE OF THREE METHODS TO DETERMINE K VALUES FOR EYES PREVIOUSLY TREATED WITH LASIK. THE DATA CONFIRM THAT NONE OF THE THREE METHODS WERE USED. FURTHERMORE, THE PRINTED PREOPERATIVE CALCULATIONS SHEET DISPLAYS THE MESSAGE "THE MEASUREMENTS SHOULD BE CHECKED FOR PLAUSIBILITY, AS THERE MAY BE PATHOLOGICAL CHANGES!" WHICH INDICATES THAT THE IOLMASTER HAD PREVIOUSLY PROVIDED THE FOLLOWING POP UP WARNING MESSAGE DURING MEASUREMENT WORKFLOW: !" MULTIPLE PEAKS CHECK THAT THERE ARE NO PATHOLOGICAL CHANGES TO THE EYE! OK. " SITE CONTACT: (B)(6), USA.

    Description of Event or Problem · 1

    AFTER UNDERGOING SURGERY TO IMPLANT, AN INTRAOCULAR LENS ON A POST-LASIK PT, THE PT EXPERIENCED A POOR POST-OPERATIVE OUTCOME OF +4 DIOPTERS POSTOPERATIVE REFRACTION INSTEAD OF THE EXPECTED TARGET REFRACTION OF -1.1 DIOPTERS. AS A RESULT, THE PT UNDERWENT A SECOND SURGERY TO IMPROVE THE POST-OPERATIVE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126497 IOLMASTER BIOMICROSCOPE, SLIT-LAMP, AC-POWERED HJO CARL ZEISS MEDITEC AG (JENA SITE) NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention