BEUDAMED
    FDA Adverse Event Injury Summary report: N

    255

    MDR report key: 17566788 · Received August 17, 2023

    Report

    Report Number
    3006723646-2023-00415
    Event Type
    Injury
    Date Received
    August 17, 2023
    Date of Event
    July 6, 2023
    Report Date
    August 14, 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 AND FINAL REPORT IS BEING SUBMITTED TO FDA FOR A REPORTABLE EVENT THAT OCCURRED OUTSIDE THE USA. THE PRODUCT WAS RETURNED TO THE MANUFACTURER. THE INVESTIGATION WAS CONDUCTED, WITH THE METHODS AND RESULTS AS NOTED BELOW. NO ABNORMALITIES WERE FOUND IN PRODUCTION AND INSPECTION RECORDS OF THE PRODUCT.(SERIAL NO.: (B)(6); MODEL: 255) IN ADDITION, WE DIDN'T RECEIVE ANY OTHER SIMILAR COMPLAINTS ON THE SAME MANUFACTURING LOT FROM OTHER HOSPITALS. (B)(4). THE DYE TEST RESULT SHOWED THE INJECTOR TIP WAS PROPERLY COATED. PROPER COATING ALLOWS THE LENS TO ADVANCE. WE COULD RELEASE A RE-INSTALLED IOL FROM THE RETURNED INJECTOR WITHOUT ANY PROBLEMS. THE EXACT ROOT CAUSE OF THE EVENT WAS NOT DETERMINED. HOWEVER, 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

    EVENT OCCURRED IN JAPAN. DAMAGED HAPTIC AFTER IMPLANTATION. THE DOCTOR EXPLANTED THE IOL FROM THE EYE SINCE HE FOUND THE TRAILING HAPTIC WAS SEPARATED JUST AFTER IMPLANTATION. PATIENT IMPACT: DEVICE EXPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994208 255 INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS, INC. 255 (+ 21.50 D)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention