BEUDAMED
    FDA Adverse Event Injury Summary report: N

    250

    MDR report key: 18196907 · Received November 22, 2023

    Report

    Report Number
    3006723646-2023-00451
    Event Type
    Injury
    Date Received
    November 22, 2023
    Date of Event
    August 18, 2023
    Report Date
    January 18, 2024
    Manufacturer
    HOYA SURGICAL OPTICS, INC.
    Product Code
    HQL
    UDI-DI
    04547480480787
    PMA / PMN Number
    P080004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP #1 EMDR IS BEING SUBMITTED TO FDA FOR AN EVENT THAT OCCURRED OUTSIDE OF THE USA. THE REPORT INCLUDES ADDITIONAL INFORMATION NOT AVAILABLE/INCLUDED IN THE INITIAL REPORT. THE PRODUCT WAS RETURNED TO THE MANUFACTURER. THE INVESTIGATION WAS CONDUCTED, WITH THE METHODS AND RESULTS AS NOTED BELOW. POTENTIAL HARM OF THIS COMPLAINT CATEGORY IS DEFINED AS "NEGLIGIBLE" OR "MINOR", AND THE COMPLAINT RATE DOESN'T REACH ITS ACTION/ALERT LEVEL. IN ADDITION, THIS IS NOT A CUSTOMER LETTER/AE REPORT REQUIRED CASE. SO, WE COMPLETED THIS PROCESS WITH TREND ANALYSIS AND APPEARANCE CHECK. APPEARANCE CHECK RESULT WAS CONSISTENT TO REPORTED INFORMATION. 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.

    Additional Manufacturer Narrative · 0

    THIS INITIAL EMDR IS BEING SUBMITTED TO FDA FOR AN EVENT THAT OCCURRED OUTSIDE OF THE USA. INJECTOR MALFUNCTION IS INDICATED AS A POTENTIAL MALFUNCTION RELATED TO THE IOL, AS COVERED UNDER THE WARNINGS SECTION OF THE PRODUCT'S INSTRUCTIONS FOR USE (IFU). REGARDING SECTION H6 - MANUFACTURER'S CODES FOR: TYPE OF INVESTIGATION, FINDINGS, AND CONCLUSION ARE PENDING DEVICE RETURN AND COMPLETION OF PRODUCT INVESTIGATION. ONCE THE PRODUCT INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED TO FDA WHICH WILL INCLUDE THE MANUFACTURER'S CODES FOR TYPE OF INVESTIGATION, FINDINGS, AND CONCLUSION.

    Description of Event or Problem · 0

    EVENT OCCURRED IN MALAYSIA. IOL GOT STUCK DURING SCREW ROTATION DUE TO INJECTOR MALFUNCTION DURING IOL INSERTION IMDRF CODE: A050301, FAILURE TO EJECT. IOL WAS EXPLANTED ON (B)(6) 2023.

    Description of Event or Problem · 0

    EVENT OCCURRED IN MALAYSIA. IOL GOT STUCK DURING SCREW ROTATION DUE TO INJECTOR MALFUNCTION DURING IOL INSERTION. IMDRF CODE: A050301, FAILURE TO EJECT. IOL WAS EXPLANTED ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2041219 250 INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS, INC. 250 (+ 20 D) 04547480480787

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown