BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROVIEW INTRAOCULAR LENS

    MDR report key: 2960287 · Received February 8, 2013

    Report

    Report Number
    1119279-2013-00036
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 11, 2013
    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 REQUESTED BUT NOT RETURNED TO BAUSCH + LOMB. DESPITE ATTEMPTS TO OBTAIN THE LENS LOT NUMBER, IT WAS NOT PROVIDED. THEREFORE, A REVIEW OF THE LOT HISTORY RECORD COULD NOT BE PERFORMED. SINCE THE LENS WAS NOT RETURNED IT IS NOT POSSIBLE TO CONFIRM WHETHER THE OPACIFICATION OBSERVED BY THE PHYSICIAN IS DUE TO CALCIFICATION OR SOME OTHER MECHANISM. 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 ONTO THE SURFACE OF THE IOL MOST LIKELY DUE TO ENVIRONMENTAL CIRCUMSTANCES (EG, 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. BASED ON THE CURRENT INFORMATION, THE EXACT ROOT CAUSE OF THE IOL OPACIFICATION CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HYDROVIEW INTRAOCULAR LENS WAS EXPLANTED DUE TO OPACIFICATION. THE LOT AND SERIAL NUMBER WERE NOT PROVIDED, THEREFORE IT HAS NOT BEEN POSSIBLE TO DETERMINE WHETHER THE LENS MODEL IS HYDROVIEW 1.0. ADDITIONAL INFORMATION WAS REQUESTED BUT HAS NOT BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53560 HYDROVIEW INTRAOCULAR LENS HQL / INTRAOCULAR LENS HQL BAUSCH + LOMB H60M

    Patients

    Seq Age Sex Outcome Treatment
    1 Other