BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISYMM INTRAOCULAR LENS

    MDR report key: 3983386 · Received July 7, 2014

    Report

    Report Number
    3006723646-2014-00356
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    HOYA SURGICAL OPTICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P080004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR FOLLOW-UP REPORT #1 IS BEING SUBMITTED AT THIS TIME AS THE COMPLAINT INVESTIGATION WAS NOT DETECTED IN THE PRODUCT COMPLAINT HANDLING SYSTEM ((B)(4)) DUE TO UNEXPECTED SOFTWARE ISSUES. THE PURPOSE OF THIS FOLLOW-UP REPORT #1 IS TO REVISE "DEVICE MANUFACTURE DATE" OF 02/2015 TO 02/28/2014. THIS SUPPLEMENT IS ALSO UPDATING THE AGENCY ON INFORMATION OF PRODUCT ANALYSIS. AS PRODUCT WAS NOT RETURNED, EVALUATION COULD ONLY CONSIST OF A REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS OF THE DEVICE. NO ABNORMALITIES WERE FOUND IN PRODUCTION AND INSPECTION RECORDS OF THE PRODUCT. (SERIAL NO.: (B)(4); MODEL FY60AD.) THE EXACT ROOT CAUSE WAS NOT DETERMINED. THE FOLLOWING ADDITIONAL INFORMATION HAS BEEN ADDED TO THIS FOLLOW-UP REPORT. UNIQUE DEVICE IDENTIFIER (UDI) NUMBER HAS BEEN ADDED. PRODUCT WAS NOT RETURNED.

    Description of Event or Problem · 1

    HAPTIC BROKE OFF RIGHT AFTER BEING IMPLANTED INTO PATIENT'S EYE. THE LENS HAD TO BE EXPLANTED.

    Description of Event or Problem · 1

    HAPTIC BROKE OFF RIGHT AFTER BEING IMPLANTED INTO PTS EYE. LENS HAD TO BE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395061 ISYMM INTRAOCULAR LENS INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS, INC. FY-60AD (+23.00D) AJ200

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention