BEUDAMED
    FDA Adverse Event Other Summary report: N

    ISERT ASPHERIC INTRAOCULAR LENS

    MDR report key: 2214206 · Received July 21, 2011

    Report

    Report Number
    3006723646-2011-00164
    Event Type
    Other
    Date Received
    July 21, 2011
    Date of Event
    May 3, 2010
    Report Date
    July 21, 2011
    Manufacturer
    HOYA SURGICAL OPTICS, INC.
    Product Code
    HQL
    PMA / PMN Number
    P080004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    HOYA SURGICAL OPTICS (HSO) FIRST RECEIVED THIS COMPLAINT ON (B)(6) 2010. IT WAS INITIALLY DETERMINED THAT AN MDR WAS NOT REQUIRED BECAUSE THERE WAS NO PATIENT INJURY, PATIENT WAS DOING WELL, AND MANUFACTURING RECORDS VERIFIED THAT THE DEVICE WAS FREE OF DEFECTS BEFORE RELEASE TO MARKET (I.E., THE ALLEGED DEFECT OCCURRED DURING USE BY THE DOCTOR). HSO PERFORMED A REVIEW FOR THIS COMPLAINT IN (B)(4) 2011 AND DETERMINED THAT EVEN THOUGH THERE WAS NO PATIENT INJURY IN THIS COMPLAINT, AN INJURY MAY BE POSSIBLE IF THIS COMPLAINT WERE TO RECURE. HENCE, WER ARE SUBMITTING AN MDR FOR THIS COMPLAINT PER FDA GUIDANCE DOCUMENT (B)(4).

    Description of Event or Problem · 1

    AFTER LENS INSERTION, DOCTOR NOTICED A SMALL PIECE OF OPTIC SEEMED TO BE MISSING. LENS IS STILL IN PATIENT'S EYE AND PATIENT APPEARS TO BE DOING WELL. LENS NOT EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISERT ASPHERIC INTRAOCULAR LENS HQL HOYA SURGICAL OPTICS, INC. PY-60AD

    Patients

    Seq Age Sex Outcome Treatment
    1