BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDROVIEW INTRAOCULAR LENS

    MDR report key: 4840261 · Received June 10, 2015

    Report

    Report Number
    1313525-2015-01572
    Event Type
    Injury
    Date Received
    June 10, 2015
    Report Date
    January 14, 2015
    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

    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. VISUAL INSPECTION OF THE RETURNED LENS FOUND THE OPTIC NEARLY CUT IN HALF AND BOTH HAPTICS ATTACHED AND NOT DAMAGED. THE OPTIC HAS A CLOUDY WHITE APPEARANCE AND SOME SURFACE AREAS WITH AN ORANGE PEEL APPEARANCE. AN ALIZARIN RED S CHEMICAL STAIN TEST WAS PERFORMED TO DETERMINE IF CALCIUM IS PRESENT ON THE LENS. LARGE AREAS OF THE OPTIC DID TURN RED CONFIRMING CALCIUM. 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 TISSUES 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 CASED 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 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
    374989 HYDROVIEW INTRAOCULAR LENS INTRAOCULAR LENS HQL BAUSCH & LOMB H60M

    Patients

    Seq Age Sex Outcome Treatment
    1 Other