BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISERT ASPHERIC INTRAOCULAR LENS

    MDR report key: 4777628 · Received May 15, 2015

    Report

    Report Number
    3006723646-2015-00410
    Event Type
    Malfunction
    Date Received
    May 15, 2015
    Report Date
    May 14, 2015
    Manufacturer
    HOYA SURGICAL OPTICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P080004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PURPOSE OF THIS SUPPLEMENT IS TO REVISE SECTION D2 FROM "HQL" TO "INTRAOCULAR LENS" AND ADD "HQL" TO SECTION D2B PROCODE. SECTION D10 CHANGED TO "YES" (DEVICE AVAILABLE) AND ADD DATE OF RETURN TO MANUFACTURER, AND H3 FORM "NOT RETURNED" TO "YES" WITH EVALUATION SUMMARIZED BELOW. THIS SUPPLEMENT IS ALSO UPDATING THE AGENCY ON NEW INFORMATION PROVIDED BY THE CUSTOMER WHICH DOCUMENTED THAT THE INCISION WAS NOT ENLARGED IN ORDER TO REMOVE THE LENS, AND THAT THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION OBTAINED FROM THE PRODUCT INVESTIGATION COMPLETED BY (B)(4) QUALITY ASSURANCE DEPARTMENT, ON 06/15/2015, FOUND THAT: THE LENS WAS EJECTED OUT OF THE INJECTOR AND WAS EXPLANTED. LENS WAS NOT RETURNED. ONE HAPTIC WAS TORN AT TIP AND THE TORN HAPTIC PIECE REMAINED INSIDE THE INJECTOR TIP. THE SLIDER WAS FULLY ADVANCED AND THE ROD WAS ADVANCED PARTIALLY. TRACE OF LUBRICANT WAS FOUND INSIDE THE INJECTOR TIP. A REVIEW OF THE PRODUCTION RECORDS SHOWED NO IRREGULARITIES OR ABNORMALITIES DURING ITS MANUFACTURING AND/OR INSPECTION PROCESSES. THE EXACT CAUSE IN THIS CASE COULD NOT BE ASCERTAINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT RIGHT AFTER IMPLANT THE HAPTIC HAD TORN OFF AFTER IMPLANTATION , AND LENS HAD TO BE EXPLANTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT RIGHT AFTER IMPLANT THE HAPTIC HAD TORN OFF ABOUT IMPLANTATION, AND LENS HAD TO BE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318121 ISERT ASPHERIC INTRAOCULAR LENS INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS, INC. 250

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention