BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROVIEW INTRAOCULAR LENS

    MDR report key: 3931409 · Received June 26, 2014

    Report

    Report Number
    1119279-2014-00151
    Event Type
    Injury
    Date Received
    June 26, 2014
    Report Date
    May 30, 2014
    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 IMPLANTED IN 2001. HYDROVIEW IOL WAS DISCONTINUED AND IS NO LONGER MANUFACTURED BY B+L. DESPITE ATTEMPTS TO OBTAIN THE LENS LOT NUMBER, IT WAS NOT PROVIDED. THEREFORE, A REVIEW OF THE LOT HISTORY RECORD COULD NOT BE PERFORMED. THE LENS IS NOT AVAILABLE TO BE RETURNED TO B+L FOR EVALUATION. THEREFORE, IT IS NOT POSSIBLE TO CONFIRM WHETHER THE REPORTED OPACIFICATION 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 INFORMATION PROVIDED, THE EXACT ROOT CAUSE FOR THIS EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HYDROVIEW INTRAOCULAR LENS IS SCHEDULED TO BE 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
    372919 HYDROVIEW INTRAOCULAR LENS HQL / INTRAOCULAR LENS HQL BAUSCH & LOMB H60M

    Patients

    Seq Age Sex Outcome Treatment
    1 Other