BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS AO INTRAOCULAR LENS

    MDR report key: 4081111 · Received August 28, 2014

    Report

    Report Number
    1119279-2014-00207
    Event Type
    Injury
    Date Received
    August 28, 2014
    Report Date
    July 29, 2014
    Manufacturer
    BAUSCH & LOMB
    Product Code
    HQL
    PMA / PMN Number
    P060022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SEVERAL MONTHS POST-OPERATIVE LENS HAS TILTED, ONE PAIR OF HAPTICS APPEARS TO BE BENT/CURLED ALMOST AT 90 DEGREES. UNEVEN CAPSULAR CONTRACTION WAS ALSO OBSERVED. REFRACTION AT 1 MONTH WAS -.75 + 1.00 AT 170. ON (B)(6) 2014 REFRACTION WAS -4.50 + 2.00 AT 105. PATIENT HAS BLURRY VISION. NO SECONDARY INTERVENTION HAS BEEN REPORTED TO DATE. ADD'L INFO HAS BEEN REQUESTED BUT NO NEW INFO HAS BEEN REC'D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523729 AKREOS AO INTRAOCULAR LENS INTRAOCULAR LENS HQL BAUSCH & LOMB A060 1211205

    Patients

    Seq Age Sex Outcome Treatment
    1 Other