BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    25500B

    MDR report key: 18705942 · Received February 14, 2024

    Report

    Report Number
    3006723646-2024-00014
    Event Type
    Malfunction
    Date Received
    February 14, 2024
    Date of Event
    January 10, 2024
    Report Date
    April 23, 2024
    Manufacturer
    HOYA SURGICAL OPTICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P080004
    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. CORRECTED INFORMATION: H3 - CORRECTED TO YES. 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 RETURNED TO THE MANUFACTURER. THE INVESTIGATION WAS CONDUCTED, WITH THE METHODS AND RESULTS AS NOTED BELOW. APPEARANCE CHECK RESULT WAS CONSISTENT TO REPORTED INFORMATION. THE SERIAL NUMBER WAS NOT PROVIDED SO THE PRODUCTION AND INSPECTION RECORDS OF THE PRODUCT COULD NOT BE REVIEWED. (SERIAL NO.: UNKNOWN; MODEL: 25500B). 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). 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 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 JAPAN. CONFIRMED PMMA OF TRAILING HAPTIC WAS BROKEN AND LEFT IN THE INJECTER AFTER 255 INSERTION. REQUIRE A POSSIBLE CAUSE OF THE OCCURRENCE ETC. PRODUCT PROBLEM CODE: A0414 - MATERIAL SPLIT, CUT OR TORN.

    Description of Event or Problem · 0

    EVENT OCCURRED IN JAPAN. CONFIRMED PMMA OF TRAILING HAPTIC WAS BROKEN AND LEFT IN THE INJECTOR AFTER 255 INSERTION. REQUIRE A POSSIBLE CAUSE OF THE OCCURRENCE ETC. PRODUCT PROBLEM CODE: (B)(6) - MATERIAL SPLIT, CUT OR TORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443816 25500B INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS, INC. 25500B

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown