BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EZ-28 DELIVERY SYSTEM

    MDR report key: 3841076 · Received May 16, 2014

    Report

    Report Number
    1119279-2014-00087
    Event Type
    Injury
    Date Received
    May 16, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 25, 2014
    Manufacturer
    BAUSCH & LOMB
    Product Code
    MSS
    PMA / PMN Number
    K970727
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE REFERENCE MDR# 1119279-2014-00087 FOR THE DELIVERY DEVICE AND MDR # 1119279-2014-00088 FOR VISCOELASTIC USED IN THIS EVENT. 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 A PT PRESENTED WITH SYMPTOMS CONSISTENT WITH ENDOPHTHALMITIS SEVERAL DAYS POST SURGERY. THE PROCEDURE WAS COMPLICATED DUE TO POSSIBLE POSTERIOR CAPSULE TEAR WITH NO VITREOUS LOSS OR RETAINED FRAGMENTS. THE IOL WAS PLACED IN CILIARY SULCUS WITH OPTIC CAPTURE IN CAPSULE BAG. A CLEAR CORNEAL INCISION WAS UTILIZED. ONE DAY POST-OP VISIT VISION WAS NORMAL, 2 DAYS POST-OP PT'S VISION CONTINUED TO IMPROVE, 3 DAYS POST-OP PT REPORTED SEEING NUMEROUS BLACK FLOATERS, AND SMOKEY/HAZY COVER VISION. FOUR DAYS POST-OP CORNEAL WOUND ABRASION AND LAYERED HYPOPION WERE NOTED, AND PT WAS DIAGNOSED WITH ENDOPHTHALMITIS. PT WAS REFERRED TO A RETINA DOCTOR AND PPV WITH INTRAVITREAL INJECTION OF ANTIBIOTICS WERE PERFORMED. THE PT'S VISION DECREASED FROM FINGER COUNT TO HAND MOTION. THE SURGEON INDICATED THAT IN HIS OPINION THE LIKELY CAUSE OF THE EVENT WAS CORNEAL ABRASION. THE SURGEON DOES NOT SUSPECT THAT THE IOL MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THIS EVENT REFERS TO THE PT'S LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293010 EZ-28 DELIVERY SYSTEM MSS/FOLDERS AND INJECTORS, IOL MSS BAUSCH & LOMB EZ-28

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other (B)(4) SOFPORT ADVANCED OPTIC LENS| AMVISC PLUS (B)(4) VISCOELASTIC