BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IDESIGN RS

    MDR report key: 12544639 · Received September 28, 2021

    Report

    Report Number
    2020664-2021-07508
    Event Type
    Injury
    Date Received
    September 28, 2021
    Report Date
    September 28, 2021
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    HKO
    UDI-DI
    05050474651432
    PMA / PMN Number
    K000327
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WEIGHT AND ETHNICITY UNKNOWN/NOT PROVIDED. DATE OF EVENT: UNKNOWN/NOT PROVIDED. DEVICE EVALUATION: CLINICAL REVIEWED THE IMAGES BY LOGGING IN VIRTUALLY TO THE IDESIGN TO REVIEW THE EXAMS AND TREATMENT PLANS WITH THE ACCOUNT AND NOTHING OUT OF THE ORDINARY NOTED. CAPTURES LOOKED GOOD AND VERY LITTLE DIFFERENCE SEEN BETWEEN THE MANIFEST AT OPTICAL INFINITY AND THE IDESIGN MANIFEST AT OPTICAL INFINITY. A RECORD REVIEW WAS PERFORMED. A PRODUCT DEFICIENCY REVIEW WAS PERFORMED AND THERE IS NO PRODUCT DEFICIENCY IDENTIFIED. A DOCUMENT, SERVICE HISTORY, AND TRENDING WAS REVIEWED. THERE IS NOT A RECOGNIZABLE ADVERSE TREND. THE RISKS AND MITIGATIONS ASSOCIATED WITH THE COMPLAINT ISSUE ARE IDENTIFIED IN EXISTING RISK DOCUMENTS AND NO NEW RISKS WERE IDENTIFIED AS PART OF THIS INVESTIGATION. A LABELING REVIEW WAS CONDUCTED; THE OPERATOR MANUAL FOR THE SYSTEM WAS REVIEWED AND FOUND TO INCLUDE ADEQUATE INSTRUCTIONS FOR USE, WARNINGS AND OPERATIONAL ERRORS. THE REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR IDESIGN SYSTEM SHOWED THAT THERE WERE NO ISSUES OR NON-CONFORMITIES. THE SYSTEM AND ITS COMPONENTS MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED. MANUFACTURING HAS BEEN RULED OUT AS A POTENTIAL CAUSE FOR THE REPORTED ISSUE. BASED ON THE INVESTIGATION RESULTS, NO CORRECTIVE ACTION HAS BEEN ISSUED. BASED ON THE INVESTIGATION RESULTS THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. JOHNSON & JOHNSON SURGICAL VISION WILL CONTINUE TO MONITOR THIS TYPE OF COMPLAINTS. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS TREATED (B)(6) 2020 WITH IDESIGN AND PHOTOREFRACTIVE KERATECTOMY (PRK) THAT WAS OVERCORRECTED. THE PATIENT WAS RETREATED IN (B)(6) 2021 AND CURRENTLY IS DOING WELL. ORIGINAL RIGHT (OD) EYE TREATMENT (RX) WAS -6.00 +0.25 AND THE PATIENT ENDED UP BEING +1.25 +.25. THERE WAS NO LOSS OF BEST CORRECTED VISUAL ACUITY (BCVA) REPORTED. THIS REPORT IS FOR THE IDESIGN SYSTEM. A SEPARATE REPORT WILL BE SUBMITTED FOR EXCIMER LASER SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1442539 IDESIGN RS OPHTHALMIC REFRACTOMETER HKO AMO MANUFACTURING USA, LLC 0110-3450 05050474651432

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention