BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PY-60AD

    MDR report key: 17402440 · Received July 27, 2023

    Report

    Report Number
    3006723646-2023-00364
    Event Type
    Injury
    Date Received
    July 27, 2023
    Date of Event
    November 7, 2021
    Report Date
    July 25, 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 NEW THAILAND FACILITY FROM 03-06 APRIL 2023. THEREFORE, A US FDA EMDR REPORT IS BEING SUBMITTED TO CORRECT THIS OMISSION. PORTIONS OF THE PRODUCT WERE 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: PY-60AD). WE ALSO CONFIRMED THERE WERE NOT ANY ABNORMALITIES ON THE LOOP PULL STRENGTH TEST RECORD OF THE MATERIAL LOT. (SYUA-60-01) 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 CHINA. ORIGINALLY ASSESSED AS NOT REPORTABLE TO LOCAL AUTHORITIES. INTRA-OPERATIVE COMPLICATIONS, POSTERIOR CAPSULE RUPTURE, TUCKING FAILURE DEFORMED HAPTIC AFTER IMPLANTATION. PROBLEM CODE: A040609 MATERIAL TWISTED / BENT. DATE OF EVENT: (B)(6) 2021. PATIENT HEALTH IMPACT: INSUFFICIENT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322514 PY-60AD INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS, INC. PY-60AD (+21.50 D)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other