BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS AO MICRO INCISION LENS

    MDR report key: 1830783 · Received September 8, 2010

    Report

    Report Number
    1920664-2010-00212
    Event Type
    Injury
    Date Received
    September 8, 2010
    Report Date
    August 11, 2010
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P060022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LENS IS SOLD IN THE USA UNDER MODEL MI60LUS.

    Description of Event or Problem · 1

    AFTER CATARACT SURGERY, THE PATIENT PRESENTED WITH SEVERE PHIMOSIS. ANTERIOR CAPSULE YAG LASER RADIAL CUTS WERE REQUIRED TO TREAT THE PHIMOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AKREOS AO MICRO INCISION LENS HQL BAUSCH & LOMB MI60G

    Patients

    Seq Age Sex Outcome Treatment
    1 Other