BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROVIEW INTRAOCULAR LENS

    MDR report key: 2960285 · Received February 8, 2013

    Report

    Report Number
    1119279-2013-00040
    Event Type
    Injury
    Date Received
    February 8, 2013
    Report Date
    December 12, 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

    ACCORDING TO THE INFO RECEIVED, THE LENS EXPLANT IS PLANNED FOR MARCH OR APRIL OF 2013. HOWEVER, THE EXACT SURGERY DATE HAS NOT BEEN PROVIDED. 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 HAS NOT YET BEEN EXPLANTED 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 (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. BASED ON THE CURRENT INFO, THE EXACT ROOT CAUSE OF THE IOL OPACIFICATION CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LENS EXPLANTATION WAS PLANNED DUE TO OPACIFICATION. THE EXACT SURGERY DATE WAS NOT PROVIDED. THE LOT AND SERIAL NUMBER WERE NOT PROVIDED, THEREFORE IT HAS NOT BEEN POSSIBLE TO DETERMINE WHETHER THE LENS MODEL IS HYDROVIEW 1.0. ADD'L INFO WAS REQUESTED BUT HAS NOT BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54873 HYDROVIEW INTRAOCULAR LENS HQL / INTRAOCULAR LENS HQL BAUSCH & LOMB H60M

    Patients

    Seq Age Sex Outcome Treatment
    1 Other