BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRYSTALENS

    MDR report key: 1843550 · Received September 22, 2010

    Report

    Report Number
    2031924-2010-00165
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    July 27, 2010
    Report Date
    July 29, 2010
    Manufacturer
    BAUSCH + LOMB
    Product Code
    NAA
    PMA / PMN Number
    P030002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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: THE SURGEON REPORTS THAT THE CAPSULE DAMAGE WAS LIKELY CAUSED BY MANIPULATION/POSITIONING OF THE LENS.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF THE CRYSTALENS USING THE CRYSTALSERT INJECTOR SYSTEM. THE SURGEON HAD DIFFICULTY POSITIONING THE IOL AND THE CAPSULE BECAME DAMAGED AND THERE WAS VITREOUS LOSS. INTERVENTION WAS PERFORMED TO ENLARGE AND SUTURE THE INCISION AND REMOVE AND REPLACE THE LENS WITH A SULCUS-FIXATED LENS. A VITRECTOMY WAS ALSO PERFORMED AND THE PATIENT WAS REFERRED TO A RETINAL SPECIALIST. REFERENCE MDR #2031924-2010-00166.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALENS INTRAOCULAR LENS NAA BAUSCH + LOMB AT50AO 018447

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention CRYSTALSERT LENS INJECTOR (B+L)