BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M-PORT SI INJECTOR

    MDR report key: 4894184 · Received July 1, 2015

    Report

    Report Number
    1313525-2015-01986
    Event Type
    Injury
    Date Received
    July 1, 2015
    Report Date
    June 1, 2015
    Manufacturer
    BAUSCH & LOMB INCORPORATED
    Product Code
    MSS
    PMA / PMN Number
    K970727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DELIVERY DEVICE WAS NOT PROVIDED, AND THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, A DEVICE HISTORY REVIEW (DHR) AND PRODUCT EVALUATION COULD NOT BE CONDUCTED. IT IS POSSIBLE THAT USER RELATED FACTORS (SUCH AS LOADING OR HANDLING TECHNIQUES) AND/OR PROCEDURAL FACTORS (SUCH AS LENS AND INSERTER INTERACTION) MIGHT HAVE CONTRIBUTED TO THE EVENT. THE MOST PROBABLE ROOT CAUSE FOR THE HAPTIC BREAKAGE IS ASSOCIATED WITH A SPECIFIC LOT OF HAPTIC MATERIAL THAT WAS USED FOR THE MANUFACTURE OF THE LENS INVOLVED IN THIS EVENT. AN INVESTIGATION HAS BEEN OPENED TO ADDRESS THIS ISSUE. FURTHERMORE, BAUSCH + LOMB INITIATED A RECALL FOR ALL LENSES MANUFACTURED WITH THE HAPTIC MATERIAL LOT IN QUESTION.

    Additional Manufacturer Narrative · 1

    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 SUBSEQUENT TO INSERTING THE LENS INTO THE EYE USING AN INJECTOR, THE LENS TRAILING HAPTIC WAS FOUND TO BE "TOO SHORT." THE INCISION WAS ENLARGED, THE LENS WAS REMOVED AND 2 SUTURES WERE PLACED. THE LENS WAS REPLACED WITH ANOTHER LENS OF THE SAME MODEL. THIS REPORT REFERENCES THE INSERTER USED DURING THE EVENT. REFERENCE MDR#1313525-2015-01985 FOR THE LENS USED DURING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426601 M-PORT SI INJECTOR INTRAOCULAR LENS GUIDE MSS BAUSCH & LOMB INCORPORATED EZ-28

    Patients

    Seq Age Sex Outcome Treatment
    1 Other