BEUDAMED
    FDA Adverse Event Injury Summary report: N

    255

    MDR report key: 17015330 · Received May 26, 2023

    Report

    Report Number
    3006723646-2023-00053
    Event Type
    Injury
    Date Received
    May 26, 2023
    Date of Event
    March 29, 2023
    Report Date
    May 9, 2023
    Manufacturer
    HOYA SURGICAL OPTICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P080004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INITIAL REPORT IS BEING SUBMITTED TO FDA FOR A REPORTABLE EVENT THAT OCCURRED OUTSIDE THE USA. NOTE: DELAYED EMDR SUBMISSION WAS DUE TO FDA ESG WEBTRADER ACCOUNT SYSTEM SOFTWARE ISSUES, PER FDA ESG HELP DESK TICKET # 352650. HOYA DUE DILIGENCE IS DOCUMENTED UNDER INTERNAL ISSUE-0807. HAPTIC DAMAGE IS INDICATED AS A POTENTIAL MALFUNCTION RELATED TO THE IOL, AS COVERED UNDER THE WARNINGS SECTION OF THE PRODUCT'S INSTRUCTIONS FOR USE (IFU). THE PRODUCT WAS RETURNED TO THE MANUFACTURER. THE INVESTIGATION WAS CONDUCTED, WITH THE METHODS AND RESULTS AS NOTED BELOW. APPEARANCE CHECK RESULT WAS CONSISTENT TO REPORTED INFORMATION. NO ABNORMALITIES WERE FOUND IN PRODUCTION AND INSPECTION RECORDS OF THE PRODUCT. (SERIAL NO.: TDMX1HL2; MODEL: 255). THE EXACT ROOT CAUSE OF THE EVENT WAS NOT DETERMINED. HOWEVER, BASED ON AVAILABLE INFORMATION, WE BELIEVE THIS EVENT WAS NOT CAUSED BY OUR PRODUCT QUALITY. CAPA-22-0009 HAS BEEN INITIATED FOR "DAMAGED HAPTIC" COMPLAINTS.

    Description of Event or Problem · 0

    DAMAGED HAPTIC AFTER IMPLANTATION. THE DOCTOR EXPLANTED FROM THE EYE SINCE HE FOUND THE TRAILING HAPTIC WAS SEPARATED AT TIP JUST AFTER IMPLANTATION. HE EJECTED HAPTIC PIECE FROM THE INJECTOR. (THE HAPTIC PIECE INITIALLY REMAINED IN THE INJECTOR.) THE DOCTOR DISCARDED THE INJECTOR. PATIENT IMPACT: INTRA-OPERATIVE EXPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1915490 255 INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS, INC. 255 (+ 20.00 D)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention