BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS MICS

    MDR report key: 2391432 · Received December 21, 2011

    Report

    Report Number
    1119279-2011-00264
    Event Type
    Injury
    Date Received
    December 21, 2011
    Date of Event
    July 12, 2011
    Report Date
    November 23, 2011
    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

    THE LOT HISTORY RECORD WAS REVIEWED FOR THE LENS AND THERE WERE NO NONCONFORMITIES OR ANOMALIES RELATED TO THIS COMPLAINT. THE PRODUCT WAS DEEMED ACCEPTABLE FOR RELEASE. NO OTHER COMPLAINTS FROM THE SAME LOT, FOR SIMILAR CODE, HAVE BEEN RECEIVED. THE EVENT INVESTIGATION IS UNDERWAY. THE DEVICE HAS BEEN REQUESTED FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED, A PATIENT PRESENTED WITH A POST-OPERATION REFRACTIVE ERROR IN THE RIGHT EYE. THE EXPECTED OUTCOME WAS +0.10 AND THE ACTUAL OUTCOME WAS +0.75. LENS IS IN CORRECT POSITION. SRKT FORMULA USED, STANDARD MAXITROL DROPS QDS USED POST OP. THE DOCTOR INTENDS TO PUT IN PIGGY BACK LENS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AKREOS MICS INTRAOCULAR LENS HQL BAUSCH & LOMB MI60G 1104701

    Patients

    Seq Age Sex Outcome Treatment
    1 Other