BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ADVANCED OPTIC LENS

    MDR report key: 1970342 · Received January 14, 2011

    Report

    Report Number
    1119279-2011-00012
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 16, 2010
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P910061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS HAS BEEN RETURNED TO B+L AND IS CURRENTLY UNDER EVALUATION. RESULTS WILL BE SUBMITTED TO THE FDA IN A SUPPLEMENTAL REPORT. ACCORDING TO THE SURGEON, THE MOST LIKELY CAUSE OF THE EVENT WAS DUE TO THE LENS INJECTOR. (B)(4).

    Description of Event or Problem · 1

    THE SURGEON REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF AN LI61AOR INTRAOCULAR LENS IN THE RIGHT EYE USING THE EZ-28 DELIVERY DEVICE. DURING LENS INJECTION THE TRAILING HAPTIC WAS KINKED. THE CAPSULE WAS FOUND DAMAGED. INTERVENTION WAS PERFORMED IN ORDER TO ENLARGE THE INCISION AND REMOVE THE LENS. A VITRECTOMY WAS PERFORMED. A SECOND LI61AOR INTRAOCULAR LENS WAS SUCCESSFULLY IMPLANTED IN THE SULCUS. THE INCISION WOUND WAS SUTURED. CORNEAL EDEMA AT INCISION IS BEING TREATED WITH UNSPECIFIED TOPICAL DROPS. REFERENCE MDR: 1119279-2011-00016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICONE ADVANCED OPTIC LENS INTRAOCULAR LENS HQL BAUSCH & LOMB LI61AOR 4020210

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention EZ-28 DELIVERY DEVICE (B+L)