BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISCOJECT 1.8 DELIVERY SYSTEM

    MDR report key: 2890563 · Received December 20, 2012

    Report

    Report Number
    1119279-2012-00335
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    October 9, 2012
    Report Date
    November 20, 2012
    Manufacturer
    BAUSCH & LOMB
    Product Code
    MSS
    PMA / PMN Number
    K092023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LENS HAS BEEN REQUESTED BUT WAS NOT RETURNED TO BAUSCH AND LOMB FOR EVAL. INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, A CAPSULAR TEAR OCCURRED REQUIRING AN ANTERIOR VITRECTOMY AND INTRAOPERATIVE LENS EXCHANGE. AN ANTERIOR CHAMBER LENS WAS IMPLANTED SUCCESSFULLY. THIS REPORT REFERS TO THE PT'S RIGHT EYE. THE PT WAS SENT TO A RETINAL SURGEON AND A PARS PLANA VITRECTOMY WAS PERFORMED ON (B)(6) 2012. THE PT WAS PRESCRIBED EYE DROPS. PLEASE REFERENCE MDR #: 1119279-2012-00334 FOR THE INTRAOCULAR LENS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other AKREOS ADVANCED OPTICS ASPHERIC LENS