BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOYA 255

    MDR report key: 16000903 · Received December 16, 2022

    Report

    Report Number
    3006723646-2022-00159
    Event Type
    Injury
    Date Received
    December 16, 2022
    Date of Event
    November 8, 2022
    Report Date
    November 17, 2022
    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. 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). PORTIONS OF THE PRODUCT WERE RETURNED TO THE MANUFACTURER. THE INVESTIGATION WAS CONDUCTED, WITH THE METHODS AND RESULTS AS NOTED BELOW. APPEARANCE CHECK RESULT WAS CONSISTENT WITH THE REPORTED INFORMATION. NO ABNORMALITIES WERE FOUND IN PRODUCTION AND INSPECTION RECORDS OF THE PRODUCT. (SERIAL NO.: (B)(4); MODEL: 255). EXACT ROOT CAUSE WAS NOT DETERMINED. HOWEVER, BASED ON THE AVAILABLE INFORMATION AND OUR INVESTIGATION, 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 CUT AND EXPLANTED THE IOL FROM THE EYE SINCE HE/SHE NOTICED THE TRAILING HAPTIC WAS SEPARATED AND THE OPTIC GOT CRACKED. PATIENT IMPACT: INTRA-OPERATIVE EXPLANTATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2747723 HOYA 255 INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS, INC. HOYA 255 (+16.50 D)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention