BEUDAMED
    FDA Adverse Event Injury Summary report: N

    255

    MDR report key: 18567664 · Received January 23, 2024

    Report

    Report Number
    3006723646-2024-00007
    Event Type
    Injury
    Date Received
    January 23, 2024
    Date of Event
    December 20, 2023
    Report Date
    April 12, 2024
    Manufacturer
    HOYA SURGICAL OPTICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P080004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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. THE PRODUCT WAS RETURNED TO THE MANUFACTURER. THE INVESTIGATION WAS CONDUCTED, WITH THE METHODS AND RESULTS AS NOTED BELOW. APPEARANCE CHECK RESULT WAS CONSISTENT TO REPORTED INFORMATION. NO ABNORMALITIES WERE FOUND IN PRODUCTION AND INSPECTION RECORDS OF THE PRODUCT. (SERIAL NO.: (B)(6); MODEL: 255). THE DYE TEST RESULT SHOWED THE INJECTOR TIP WAS PROPERLY COATED. WE COULD RELEASE THE RE-INSTALLED IOL FROM THE RETURNED INJECTOR 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. CAPA-22-0009 HAS BEEN INITIATED FOR DAMAGED HAPTICS COMPLAINTS.

    Additional Manufacturer Narrative · 0

    THIS INITIAL REPORT IS BEING SUBMITTED TO FDA FOR A REPORTABLE EVENT THAT OCCURRED OUTSIDE THE USA. DAMAGED HAPTIC AFTER IMPLANTATION 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

    DAMAGED HAPTIC AFTER IMPLANTATION. CONFIRMED THE TRAILING HAPTIC WAS DETACHED. THERE WAS NO DISCOMFORT WHENTHE SCREW WAS ADVANCED. INTRA-OPERATIVE EXPLANTATION. THE IOL WAS CUT AND EXPLANTED ON (B)(6) 2023. PRODUCT PROBLEM CODE: A0414, MATERIAL SPLIT, CUT OR TORN.

    Description of Event or Problem · 0

    EVENT OCCURRED IN JAPAN. DAMAGED HAPTIC AFTER IMPLANTATION. HAPTIC WAS NOTICED TO BE SEPARATED JUST AFTER IOL INSERTION. EXPLANTED IOL. INSERTED A BACKUP IOL. THE OPERATION WAS COMPLETED WITHOUT ANY PROBLEMS. INTRA-OPERATIVE EXPLANTATION; EXPLANTATION DATE: ON (B)(6) 2023. PRODUCT PROBLEM CODE: A0414, MATERIAL SPLIT, CUT OR TORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1898050 255 INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS, INC. 255 (+ 21.5 D)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention