BEUDAMED
    FDA Adverse Event Injury Summary report: N

    250

    MDR report key: 17434066 · Received August 1, 2023

    Report

    Report Number
    3006723646-2023-00301
    Event Type
    Injury
    Date Received
    August 1, 2023
    Date of Event
    February 19, 2021
    Report Date
    July 28, 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
    CH
    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 (B)(4) FACILITY FROM (B)(6) 2023. THEREFORE, A US FDA EMDR REPORT IS BEING SUBMITTED TO CORRECT THIS OMISSION. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. THE INVESTIGATION WAS CONDUCTED, WITH THE METHODS AND RESULTS AS NOTED BELOW. NO ABNORMALITIES WERE FOUND IN THE PRODUCTION AND INSPECTION RECORDS OF THE PRODUCT. (SERIAL NO.: (B)(6); MODEL: 250). 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 OCCURED IN CHINA. ORIGINALLY ASSESSED AS NOT REPORTABLE TO LOCAL AUTHORITIES. PROBLEM CODE: A040101 DEVICE APPEARS TO TRIGGER REJECTION. IMPLANT DATE: (B)(6) 2021. EXPLANT DATE: N/A. PATIENT IMPACT: SIGNS OF INFLAMMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1697634 250 INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS, INC. 250 (+ 22.50 D)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention