BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROVIEW INTRAOCULAR LENS

    MDR report key: 2792291 · Received October 12, 2012

    Report

    Report Number
    1119279-2012-00236
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    December 13, 2010
    Report Date
    February 1, 2012
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQL
    PMA / PMN Number
    P990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS WAS RETURNED FOR ANALYSIS. THE LENS OPTIC WAS RECEIVED IN TWO PIECES WITH ONE HAPTIC ATTACHED TO EACH PIECE. THE OPTIC HAS A CLOUDY WHITE APPEARANCE. AN ALIZARIN RED S CHEMICAL STAIN TEST WAS PERFORMED TO DETERMINE IF CALCIUM IS PRESENT ON THE LENS. LARGE AREAS OF THE OPTIC TURNED RED CONFIRMING THE PRESENCE OF CALCIUM DEPOSITS ON THE LENS OPTIC. THE CAUSE OF THE CALCIFICATION PHENOMENON IS MULTI-FACTORIAL. THREE MAJOR TYPES OF CALCIFICATION HAVE BEEN PREVIOUSLY DESCRIBED: THE PRIMARY FORM REFERS TO CALCIFICATION DUE TO ISSUES INHERENT TO THE IOL. THE SECONDARY FORM REFERS TO DEPOSITION OF CALCIUM UNTO THE SURFACE IF THE IOL MOST LIKELY DUE TO ENVIRONMENTAL CIRCUMSTANCES (E.G. CHANGES IN THE AQUEOUS SURROUNDING THE IMPLANTED IOL ASSOCIATED WITH PRE-EXISTING OR CONCURRENT DISEASES). BY DEFINITION, IT IS NOT RELATED TO ANY PROBLEM WITH THE IOL ITSELF. THE THIRD FORM IS A FALSE-POSITIVE OR PSEUDO-CALCIFICATION REFERS TO THOSE CASES IN WHICH OTHER PATHOLOGY IS MISTAKEN FOR CALCIFICATION OR FALSE-POSITIVE STAINING FOR CALCIUM. THE LOT NUMBER OF THE EXPLANTED LENS COULD NOT BE OBTAINED. THEREFORE IT IS UNK WHETHER THE IOL IS A HYDROVIEW 1.0 MODEL, AND A REVIEW OF THE LOT HISTORY RECORD COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HYDROVIEW INTRAOCULAR LENS WAS IMPLANTED ON (B)(6) 2001 AND EXPLANTED ON (B)(6) 2012 DUE TO OPACIFICATION OF THE LENS. THE LENS OPACIFICATION WAS NOTED ON (B)(6) 2010. THIS OCCURRED IN THE PT'S LEFT EYE. THE LOT AND SERIAL NUMBER WERE NOT PROVIDED, THEREFORE, IT HAS NOT BEEN POSSIBLE TO DETERMINE WHETHER THE MODEL NUMBER IS 1.0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROVIEW INTRAOCULAR LENS HQL/INTRAOCULAR LENS HQL BAUSCH + LOMB H60M

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other