BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOJECT 1.8 INJECTOR

    MDR report key: 1940588 · Received December 21, 2010

    Report

    Report Number
    1119279-2010-00151
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 29, 2010
    Manufacturer
    BAUSCH & LOMB
    Product Code
    MSS
    PMA / PMN Number
    K970727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE PHYSICIAN'S OPINION, THE MOST LIKELY CAUSE OF THE EVENT WAS THE LENS INJECTOR. (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTS PERFORMING CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF THE AO60G INTRAOCULAR LENS USING THE VISCOJECT 1.8 DELIVERY DEVICE. DURING IMPLANTATION, THE PHYSICIAN NOTICED THAT THE IOL DID NOT EXIT THE INJECTOR PROPERLY. ADDITIONAL INTERVENTION WAS PERFORMED TO ENLARGE THE ORIGINAL INCISION AND REMOVE THE LENS. A SECOND LENS WAS IMPLANTED SUCCESSFULLY. NO PATIENT INJURY HAS BEEN REPORTED. REFERENCE MDR # 1119279-2010-00150.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISCOJECT 1.8 INJECTOR IOL INSERTER/INJECTOR MSS BAUSCH & LOMB LP604350

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention AKREOS INTRAOCULAR LENS (B+L)