BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALSERT CRYSTALENS DELIVERY SYSTEM

    MDR report key: 1600289 · Received February 8, 2010

    Report

    Report Number
    2031924-2010-00017
    Event Type
    Injury
    Date Received
    February 8, 2010
    Date of Event
    January 5, 2010
    Report Date
    January 7, 2010
    Manufacturer
    BAUSH & LOMB SURGICAL
    Product Code
    MSS
    PMA / PMN Number
    K082944
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: ACCORDING TO THE PHYSICIAN, THE PRIMARY CAUSE OF THE REPORTED ISSUE WAS RELATED TO USE OF THE LENS INJECTOR SYSTEM, WHERE THE IOL DID NOT ADVANCE PROPERLY. (B) (4) SUTURES.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS PERFORMING CATARACT SURGERY WITH IMPLANTATION OF THE CRYSTALENS IN THE RIGHT EYE. DURING SURGERY, THE SURGEON HAD DIFFICULTY ADVANCING THE LENS THROUGH THE CRYSTALSERT LENS INJECTOR SYSTEM. THE LENS WAS REPLACED WITH A BACKUP CRYSTALENS, HOWEVER, THE HAPTICS TORE WHEN EXITING THE INJECTOR. INTERVENTION WAS PERFORMED IN ORDER TO ENLARGE THE INCISION, REMOVE THE DAMAGE LENS AND SUTURE THE INCISION. A THIRD CRYSTALENS WAS IMPLANTED SUCCESSFULLY. REFERENCE MDR #2031924-2010-00015 AND 2031924-2010-00016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALSERT CRYSTALENS DELIVERY SYSTEM IOL INSERTER/INJECTOR MSS BAUSH & LOMB SURGICAL CI-28

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CRYSTALENS IOL (B) (4)