BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    255

    MDR report key: 16281431 · Received February 1, 2023

    Report

    Report Number
    3006723646-2023-00017
    Event Type
    Malfunction
    Date Received
    February 1, 2023
    Date of Event
    January 5, 2023
    Report Date
    January 5, 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

    Narratives

    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). IFU NOT FOLLOWED - IT WAS NOTED THAT BSS WAS USED. THE PRECAUTIONS SECTION OF THE PRODUCT'S INSTRUCTIONS FOR USE (IFU) STATES: THE LENS HAS BEEN VALIDATED WITH SODIUM HYALURONATE OPHTHALMIC VISCOSURGICAL DEVICES (OVDS); THE USE OF OTHER OVDS AND LUBRICANTS MAY CAUSE DAMAGE TO THE LENS AND POTENTIAL COMPLICATIONS DURING IMPLANTATION. PORTIONS OF THE PRODUCT WERE RETURNED TO THE MANUFACTURER. THE INVESTIGATION WAS CONDUCTED, WITH THE METHODS AND RESULTS AS NOTED BELOW. THE IOL WAS NOT RETURNED. DAMAGED TRAILING HAPTIC NEAR THE TIP REMAINED IN THE INJECTOR BODY. 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. 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.

    Description of Event or Problem · 0

    DAMAGED HAPTIC AFTER IMPLANTATION IT WAS NOTED THAT BSS WAS USED. THE DOCTOR IMPLANTED IOL IN THE EYE. THE HAPTIC TIP PIECE WAS FOUND INSIDE THE INJECTOR. THE LENS WAS NOT EXPLANTED. PATIENT IMPACT: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS HEALTH IMPACT: NO HEALTH CONSEQUENCES OR IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381498 255 INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS, INC. 255 (+ 23.50 D)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other