BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ADVANCED OPTIC LENS

    MDR report key: 1915667 · Received December 1, 2010

    Report

    Report Number
    1119279-2010-00112
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    October 20, 2010
    Report Date
    November 2, 2010
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, 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.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS PERFORMING BILATERAL CATARACT SURGERY WITH IMPLANTATION OF THE (B)(4) INTRAOCULAR LENS. APPROXIMATELY FOUR YEARS POSTOPERATIVELY, THE PT RETURNED TO THE PHYSICIAN REPORTING DECREASED VISION. UPON EXAMINATION, THE PHYSICIAN REPORTS OBSERVING WHITE PUNCTATE DEPOSITS ON THE POSTERIOR IOL SURFACE IN BOTH EYES. THE IOL IN THE LEFT IS MORE AFFECTED THAN THE ONE IN THE RIGHT EYE. A YAG CAPSULOTOMY TO REMOVE THE DEPOSITS WAS NOT SUCCESSFUL. THIS REPORT PERTAINS TO THE LEFT EYE (OS). THE PT'S PREOPERATIVE BCVA IN THE LEFT EYE WAS 20/40 WITH MR +1.00 +1.00 X 165. IN (B)(4) 2010, THE PT'S BCVA WAS 20/20- WITH MR -0.25 +0.50 X 160 AND DECREASED ONE MONTH LATER TO 20/30 WITH MR -0.75 +1.00 X 160. THE LENS REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ADVANCED OPTIC LENS INTRAOCULAR LENS HQL BAUSCH & LOMB LI61AOR 4514066

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention