BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS ADAPT ADVANCED OPTICS ASPHERIC LENS

    MDR report key: 2802355 · Received October 19, 2012

    Report

    Report Number
    1119279-2012-00246
    Event Type
    Injury
    Date Received
    October 19, 2012
    Date of Event
    May 21, 2012
    Report Date
    May 22, 2012
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P060022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THREE DIFFERENT LENS SERIAL NUMBERS WERE PROVIDED BY THE CUSTOMER. HOWEVER, DESPITE MULTIPLE ATTEMPTS BAUSCH + LOMB DID NOT RECEIVE ANY INFO TO DETERMINE WHICH LENS WAS ASSOCIATED WITH THE ENLARGED INCISION. MODEL: ADAPT AO, LOT#: 1200528, SERIAL #: (B)(4), EXP DATE: 12/31/2014. MODEL: ADAPT AO, LOT#: 1202408, SERIAL #: (B)(4), EXP DATE: 01/31/2015. MODEL: ADAPT AO, LOT#: 1202408, SERIAL #: (B)(4), EXP DATE: 01/31/2015. THE DEVICE HAS BEEN DISCARDED BY THE CUSTOMER, AND THEREFORE IT IS NOT AVAILABLE FOR EVAL. INVESTIGATION OF THIS COMPLAINT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN AKREOS ADAPT AO WAS INSERTED INTO THE PT'S RIGHT EYE THE SURGEON NOTICED THAT ONE OF THE HAPTICS WAS TWISTED. THE SURGEON ENLARGED THE INCISION TO REMOVE THE LENS AND A DIFFERENT MODEL LENS WAS SUCCESSFULLY IMPLANTED. ACCORDING TO THE SURGEON, THE PT'S CURRENT PROGNOSIS IS GOOD. PLEASE REFERENCE MDR#: 1119279-2012-00247 FOR THE DELIVERY DEVICE ((B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AKREOS ADAPT ADVANCED OPTICS ASPHERIC LENS HQL / INTRAOCULAR LENS HQL BAUSCH & LOMB ADAPTAO

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other (B)(4) DELIVERY SYSTEM