BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I/A TIP 45 DEG SILICONE SLV TIP

    MDR report key: 3700960 · Received March 12, 2014

    Report

    Report Number
    1920664-2014-00022
    Event Type
    Injury
    Date Received
    March 12, 2014
    Date of Event
    February 10, 2014
    Report Date
    February 10, 2014
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQE
    PMA / PMN Number
    K934844
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL COMPLETED. ONE DP9733 I/A TIP, LOT 022513, WAS RETURNED. VISUAL INSPECTION FOUND THE ASSEMBLY HAS PARTICULATES VISIBLE ON THE TIP. HOWEVER, MICROSCOPIC EXAMINATION DID NOT FIND ANY BURRS. A FUNCTIONAL TEST WAS PERFORMED USING A SAMPLE I/A HAND PIECE. THE TIP FUNCTIONED AS INTENDED. THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    USER FACILITY IN (B)(6) REPORTED DURING SURGERY, THE ANTERIOR CAPSULE IN ANTERIOR CAPSULE AND A SMALL HOLE IN POSTERIOR CAPSULE. THE VITREOUS PROLAPSE WAS NOT BIG; HOWEVER, A VITRECTOMY WAS PERFORMED ON THE SIDE OF CAUTION. AN IOL WAS IMPLANTED INSIDE THE CAPSULE WITHOUT SUTURE. THE SURGERY WAS DELAYED AROUND 10 MINUTES. THERE WAS NO IMPACT TO THE PATIENT'S SIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149380 I/A TIP 45 DEG SILICONE SLV TIP HQE BAUSCH & LOMB, INC. 022513

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention