BEUDAMED
    FDA Adverse Event Injury Summary report: N

    151 150

    MDR report key: 17402411 · Received July 27, 2023

    Report

    Report Number
    3006723646-2023-00362
    Event Type
    Injury
    Date Received
    July 27, 2023
    Date of Event
    February 20, 2022
    Report Date
    July 25, 2023
    Manufacturer
    HOYA SURGICAL OPTICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P080004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INITIAL AND FINAL EMDR IS BEING SUBMITTED TO FDA FOR A REPORTABLE EVENT THAT OCCURRED OUTSIDE THE USA. THE DELAY IN REPORTING WAS DUE TO THE COMPLAINT BEING ORIGINALLY ASSESSED AS "NOT REPORTABLE" TO THE REGIONAL REGULATORY AUTHORITY, AND THE US FACILITY'S INCORRECT UNDERSTANDING THAT ONLY COMPLAINTS ASSESSED AS "REPORTABLE" IN THE REGION OF ORIGIN, WOULD NEED TO UNDERGO ADDITIONAL REVIEW FOR POTENTIAL REPORTABILITY TO US FDA. THE ERROR WAS NOTED DUE TO REMARKS MADE BY THE FDA AUDITOR DURING A PRE-APPROVAL INSPECTION OF THE NEW THAILAND FACILITY FROM (B)(6) 2023. THEREFORE, A US FDA EMDR REPORT IS BEING SUBMITTED TO CORRECT THIS OMISSION. THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER. THE INVESTIGATION WAS CONDUCTED, WITH THE METHODS AND RESULTS AS NOTED BELOW. THERE ARE SUSPECTED 13 SERIAL NUMBERS PROVIDED BUT THEY WERE NOT CONFIRMED WHICH ONE WAS THE DEFECTIVE CASE. NO ABNORMALITIES WERE FOUND IN PRODUCTION AND INSPECTION RECORDS OF THESE PRODUCTS. ( MODEL:150/151). THE 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. A REVIEW OF THE MOST RECENT COMPLAINT TRENDING DATA INDICATES THAT NO SIGNIFICANT TRENDS HAVE BEEN IDENTIFIED AT THIS TIME AND NO CAPA IS REQUIRED AS PART OF THE PRODUCT EVALUATION.

    Description of Event or Problem · 0

    EVENT OCCURRED IN INDONESIA. ORIGINALLY ASSESSED AS NOT REPORTABLE TO LOCAL AUTHORITIES. POST-OPERATIVE COMPLICATIONS, WITHIN 5 DAYS AFTER IMPLANTATION CELL ADHESION, VA DECREASE, DYSPHOTOPSIA. IT WAS NOTED THAT HPMC WAS USED (OFF-LABEL USE) PRODUCT MODEL - 151/150, SERIAL NUMBER NOT PROVIDED. PROBLEM CODE: A0409 MATERIAL OPACIFICATION. DATE OF EVENT: (B)(6) 2022. PATIENT HEALTH IMPACT: NO HEALTH CONSEQUENCES OR IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671575 151 150 INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS, INC. 151 150 (UNKNOWN D)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other