BEUDAMED
    FDA Adverse Event Injury Summary report: N

    250

    MDR report key: 18188554 · Received November 21, 2023

    Report

    Report Number
    3006723646-2023-00449
    Event Type
    Injury
    Date Received
    November 21, 2023
    Date of Event
    August 17, 2023
    Report Date
    January 17, 2024
    Manufacturer
    HOYA SURGICAL OPTICS, INC.
    Product Code
    HQL
    UDI-DI
    04547480480817
    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. 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: "250"). WE ALSO CONFIRMED THERE WERE NOT ANY ABNORMALITIES ON THE "LOOP PULL STRENGTH TEST" OF THE MATERIAL LOT. ("SOVJ-G115-30"). FROM OUR INVESTIGATION, WE CONFIRMED THE REPORTED EVENT. NO ROOT CAUSE WAS DETERMINED BASED ON FINDINGS OF INVESTIGATION RESULT. HOWEVER, BASED ON AVAILABLE INFORMATION, 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 EMDR IS BEING SUBMITTED TO FDA FOR AN EVENT THAT OCCURRED OUTSIDE OF THE USA. HAPTIC DAMAGE 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. DAMAGED HAPTIC AFTER IMPLANTATION. IMDRF CODE: A0414, MATERIAL SPLIT CUT OR TORN. PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY. WOUND STRETCH; INCREASED INCISION SIZE. IOL WAS EXPLANTED ON (B)(6) 2023.

    Description of Event or Problem · 0

    EVENT OCCURRED IN MALAYSIA. DAMAGED HAPTIC AFTER IMPLANTATION. IMDRF CODE: A0414, MATERIAL SPLIT CUT OR TORN. PRODUCT REPLACED WITH ANOTHER LENS IMMEDIATELY DURING SURGERY. WOUND STRETCH; INCREASED INCISION SIZE. IOL WAS EXPLANTED ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1745151 250 INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS, INC. 250 (+ 21.5 D) 04547480480817

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention