BEUDAMED
    FDA Adverse Event Injury Summary report: N

    255

    MDR report key: 18998417 · Received March 28, 2024

    Report

    Report Number
    3006723646-2024-00047
    Event Type
    Injury
    Date Received
    March 28, 2024
    Date of Event
    March 5, 2024
    Report Date
    June 6, 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 ADDITIONAL INFORMATION NOT AVAILABLE/INCLUDED IN THE INITIAL REPORT. ADDITIONAL INFORMATION: G6 - TYPE OF REPORT - NOTED AS FOLLOW-UP #1 H2 - TYPE OF FOLLOW-UP - NOTED FOR ADDITIONAL INFORMATION H6 - ADDED CODES FOR MANUFACTURER'S INVESTIGATION: TYPE; FINDINGS; AND CONCLUSION. THE PRODUCT WAS NOT 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: 255) IN ADDITION, WE DIDN'T RECEIVE ANY OTHER SIMILARCOMPLAINTS ON THE SAME MANUFACTURING LOT FROM OTHER HOSPITALS. (PT23054130) FROM OUR INVESTIGATION, WE CONFIRMED THE REPORTED EVENT. 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. 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). 255: PKG-19-317 00 EN2.MS2.254255.20190501(T)_254, 255. REGARDING SECTION H6 - MANUFACTURER'S CODES FOR: TYPE OF INVESTIGATION, FINDINGS, AND CONCLUSION ARE PENDING 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 JAPAN. DAMAGED HAPTIC AFTER IMPLANTATION. THE HAPTIC WAS TORN JUST AFTER RELEASING THE IOL INTO AN EYE. EXPLANTED IT. EXPLANTATION DATE: (B)(6) 2024. PROBLEM CODE: A0414 - MATERIAL SPLIT, CUT OR TORN.

    Description of Event or Problem · 0

    EVENT OCCURRED IN JAPAN. DAMAGED HAPTIC AFTER IMPLANTATION. THE HAPTIC WAS TORN JUST AFTER RELEASING THE IOL INTO AN EYE. EXPLANTED IT. EXPLANTATION DATE: (B)(6) 2024. PROBLEM CODE: A0414 - MATERIAL SPLIT, CUT OR TORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2129291 255 INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS, INC. 255 (+ 23.5 D)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention