BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS HD

    MDR report key: 2010943 · Received March 4, 2011

    Report

    Report Number
    2031924-2011-00049
    Event Type
    Injury
    Date Received
    March 4, 2011
    Date of Event
    April 21, 2009
    Report Date
    February 4, 2011
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE IOL IS IMPLANTED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED ISSUE.

    Description of Event or Problem · 1

    BAUSCH & LOMB RECEIVED A COMPLAINT FROM A CONSUMER WHO WAS DISSATISFIED WITH HIS VISUAL OUTCOME AFTER IMPLANTATION OF A CRYSTALENS INTRAOCULAR LENS IN HIS LEFT EYE. PATIENT REPORTED EXPERIENCING BLURRY VISION AT NEAR APPROXIMATELY FIFTEEN DAYS POSTOPERATIVELY. APPROXIMATELY FIVE MONTHS POSTOPERATIVELY, YAG WAS APPLIED TO TREAT POSTERIOR CAPSULE OPACIFICATION. ALSO, THE PATIENT WAS DIAGNOSED WITH POSTERIOR VITREOUS DETACHMENT (PVD) IN (B)(6) 2010. ACCORDING TO THE SURGEON, PVD DID NOT AFFECT THE PATIENT'S VISUAL ACUITY. APPROXIMATELY SIXTEEN MONTHS POSTOPERATIVELY THE PATIENT UNDERWENT MONOVISION CORRECTION WITH INSERTION OF A PIGGYBACK LI61SE IOL AND REPORTS THAT HIS VISION HAS IMPROVED. ACCORDING TO INFORMATION RECEIVED FROM THE SURGEON, THE REFRACTIVE ERROR WAS DUE TO LENS VAULTING. PREOPERATIVELY, THE PATIENT'S UCDVA WAS 20/30+, BCDVA WAS 20/25, WITH +0.50 SPHERE. POSTOPERATIVELY, THE PATIENT'S UCDVA IS 20/30+2, BCDVA IS 20/25, UCNVA IS 20/70, AND BCNVA IS 20/40, WITH MR OF PLANO -0.50 X150. A +2.00 D PIGGYBACK LENS WAS IMPLANTED TO ACHIEVE EMMETROPIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS HD INTRAOCULAR LENS NAA BAUSCH + LOMB HD500

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention