BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PMMA POSTERIOR CHAMBER INTRAOCULAR LENS

    MDR report key: 2003853 · Received February 24, 2011

    Report

    Report Number
    1119279-2011-00043
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    January 26, 2011
    Report Date
    January 26, 2011
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P840039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN OVERLAY COMPARISON WAS PERFORMED ON THE RETURNED LENS AND FOUND THAT THE LENS MEETS SPECIFICATIONS. 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 SURGEON REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF A PMMA INTRAOCULAR LENS. AFTER INSERTION OF THE PMMA LENS, THE SURGEON NOTED A CAPSULAR TEAR. THE LENS WAS REMOVED AND REPLACED WITH A DIFFERENT IOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PMMA POSTERIOR CHAMBER INTRAOCULAR LENS INTRAOCULAR LENS HQL BAUSCH & LOMB 8A170 2915502

    Patients

    Seq Age Sex Outcome Treatment
    1 Other