BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    255

    MDR report key: 16497929 · Received March 7, 2023

    Report

    Report Number
    3006723646-2023-00032
    Event Type
    Malfunction
    Date Received
    March 7, 2023
    Date of Event
    February 7, 2023
    Report Date
    May 11, 2023
    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 #1 EMDR IS BEING SUBMITTED TO FDA FOR A REPORTABLE EVENT THAT OCCURRED OUTSIDE OF THE USA. THE REPORT INCLUDES CORRECTED INFORMATION 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. 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. PROPER COATING ALLOWS THE LENS TO ADVANCE. WE COULD RELEASE A RE-INSTALLED IOL FROM THE RETURNED INJECTOR WITHOUT ANY PROBLEMS. THE EXACT ROOT CAUSE OF THE EVENT WAS NOT DETERMINED. HOWEVER, BASED ON AVAILABLE INFORMATION, WE BELIEVE THIS EVENT WAS NOT CAUSED BY OUR PRODUCT QUALITY. CAPA-22-0009 HAS BEEN INITIATED FOR "DAMAGED HAPTIC" 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). 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. THE DOCTOR FOUND TIP OF THE TRAILING HAPTIC WAS SEPARATED JUST AFTER IMPLANTATION. THE IOL WAS NOT EXPLANTED SINCE IT WAS STABLE IN THE BAG. PATIENT IMPACT: NOT HEALTH CONSEQUENCES OR IMPACT.

    Description of Event or Problem · 0

    DAMAGED HAPTIC AFTER IMPLANTATION. THE DOCTOR FOUND TIP OF THE TRAILING HAPTIC WAS SEPARATED JUST AFTER IMPLANTATION. THE IOL WAS NOT EXPLANTED SINCE IT WAS STABLE IN THE BAG. PATIENT IMPACT: NOT HEALTH CONSEQUENCES OR IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63697 255 INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS, INC. 255 (+ 13.00 D)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other