BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1936060 · Received December 10, 2010

    Report

    Report Number
    2031924-2010-00223
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    August 12, 2010
    Report Date
    November 12, 2010
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED ISSUE. ROOT CAUSE: ACCORDING TO THE SURGEON, THE MOST LIKELY CAUSE OF THE EVENT IN REFRACTIVE ERROR IS VAULTING, RIGHT EYE (TOO MYOPIC) AND CHANGE IN SIZE (LENGTH) OF LENS NOT RECOGNIZED BETWEEN DIOPTERS CAUSING HYPEROPIC OUTCOME IN SECOND EYE. (B)(4).

    Description of Event or Problem · 1

    THE SURGEON REPORTS PERFORMING CATARACT SURGERY WITH IMPLANTATION OF A CRYSTALENS INTRAOCULAR LENS IN BOTH EYES. THIS REPORT IS REGARDING THE CRYSTALENS IMPLANTED IN THE RIGHT EYE. APPROX SIX WEEKS POSTOPERATIVELY THE LENS WAS EXPLANTED AND REPLACED WITH A DIFFERENT IOL. THE SURGEON FOUND THERE WAS INADEQUATE ACCOMMODATION AND A REFRACTIVE ERROR SECONDARY TO VAULTING. THE PT HAD A PREOPERATIVE BCVA OF 20/60 WITH MR -3.50 -0.75 X 155 AND A UCDVA OF 20/400. POSTOPERATIVELY, THE PT'S BCVA WAS 20/20 WITH MR -1.50 -0.25 X 010 AND UCDVA WAS 20/50. THE PT'S CURRENT BCVA IS 20/20 WITH MR -0.25 AND THE UCDVA IS AND THE SPHERE. ACCORDING TO THE SURGEON THE PT'S VISUAL OUTCOME PROGNOSIS IS EXCELLENT. REFERENCE MDR #2031924-2010-00224.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS NAA BAUSCH + LOMB AT50AO 018942

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention