BEUDAMED
    FDA Adverse Event Injury Summary report: N

    251

    MDR report key: 18414486 · Received December 28, 2023

    Report

    Report Number
    3006723646-2023-00464
    Event Type
    Injury
    Date Received
    December 28, 2023
    Date of Event
    November 16, 2023
    Report Date
    March 19, 2024
    Manufacturer
    HOYA SURGICAL OPTICS, INC.
    Product Code
    HQL
    UDI-DI
    04547480450285
    PMA / PMN Number
    P080004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INITIAL EMDR IS BEING SUBMITTED TO FDA FOR AN EVENT THAT OCCURRED OUTSIDE OF THE USA. DEFORMED HAPTIC 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.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT #1 EMDR IS BEING SUBMITTED TO FDA FOR A REPORTABLE EVENT THAT OCCURRED OUTSIDE THE USA. THE REPORT INCLUDES CORRECTED AND ADDITIONAL INFORMATION NOT AVAILABLE/INCLUDED IN THE INITIAL REPORT. CORRECTED INFORMATION: H3 - CORRECTED TO YES ADDITIONAL INFORMATION: G6 - TYPE OF REPORT - NOTED AS FOLLOW-UP #1 H2 - TYPE OF FOLLOW-UP - NOTED FOR CORRECTION AND ADDITIONAL INFORMATION H6 - ADDED CODES FOR MANUFACTURER'S INVESTIGATION: TYPE; FINDINGS; AND CONCLUSION. THE PRODUCT WAS 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: 251). WE ALSO CONFIRMED THERE WERE NO ABNORMALITIES ON THE LOOP PULL STRENGTH TEST RECORD OF THE MATERIAL LOT. (TYCF-G115-10). THE DYE TEST RESULT SHOWED THE INJECTOR TIP WAS PROPERLY COATED. THE LENS RELEASE TEST RESULT SHOWED THAT THE RE-INSTALLED NEW IOL COULD BE RELEASED FROM THE RETURNED CARTRIDGE/TIP AND INJECTOR BODY WITHOUT ANY PROBLEMS. 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 AUSTRALIA. DEFORMED HAPTIC AFTER IMPLANTATION. THERE WAS POSSIBLE TO SERIOUS INJURY. MEDICAL DEVICE PROBLEM: A040609, MATERIAL TWISTED/BENT. IOL WAS EXPLANTED ON (B)(6) 2023.

    Description of Event or Problem · 0

    EVENT OCCURRED IN AUSTRALIA DEFORMED HAPTIC AFTER IMPLANTATION. THERE WAS POSSIBLE TO SERIOUS INJURY MEDICAL DEVICE PROBLEM: A040609, MATERIAL TWISTED/BENT IOL WAS EXPLANTED ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1530465 251 INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS, INC. 251 (+19.5D) 04547480450285

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention