BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    255

    MDR report key: 17067457 · Received June 5, 2023

    Report

    Report Number
    3006723646-2023-00062
    Event Type
    Malfunction
    Date Received
    June 5, 2023
    Date of Event
    April 4, 2023
    Report Date
    June 5, 2023
    Manufacturer
    HOYA SURGICAL OPTICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P080004
    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 (AND SUBSEQUENT TICKET # 359662). HOYA DUE DILIGENCE IS DOCUMENTED UNDER INTERNAL ISSUE-(B)(4). 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. THE INJECTOR AND HAPTIC PIECE WERE AVAILABLE FOR INVESTIGATION. APPEARANCE CHECK RESULT WAS CONSISTENT TO REPORTED INFORMATION. UNABLE TO REVIEW PRODUCTION AND INSPECTION RECORDS OF THE PRODUCT. (SERIAL NO.: UNKNOWN; MODEL: 255). 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, 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 NOTICED THE TRAILING HAPTIC WAS SEPARATED AT THE TIP JUST AFTER IMPLANTATION. THE IOL WAS KEPT IN THE EYE AND THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1094097 255 INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS, INC. 255 (+ 21.50 D)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other