BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS ADAPTAO INTRAOCULAR LENS

    MDR report key: 5593320 · Received April 20, 2016

    Report

    Report Number
    0001313525-2016-00158
    Event Type
    Injury
    Date Received
    April 20, 2016
    Report Date
    March 21, 2016
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQL
    PMA / PMN Number
    P060022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DESPITE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE SURGEON, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. THE LOT NUMBER OF THE LENS WAS NOT PROVIDED. THEREFORE, A DEVICE HISTORY REVIEW (DHR) COULD NOT BE CONDUCTED. THE LENS REMAINS IMPLANTED, THEREFORE IT IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. BASED ON THE INFORMATION AVAILABLE, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. PLEASE SEE ATTACHED ARTICLE "REPOSITIONING A DECENTERED INTRAOCULAR LENS WITH 4 HAPTICS" BY JIEWI LIU, MD, YADING JIA, MD, ZAINA N. AL-MOHTASEB, MD, LI WANG, MD,PHD.

    Description of Event or Problem · 1

    ARTICLE "REPOSITIONING A DECENTERED INTRAOCULAR LENS WITH 4 HAPTICS" BY JIEWI LIU, MD, YADING JIA, MD, ZAINA N. AL-MOHTASEB, MD, LI WANG, MD,PHD REPORTS THAT THE LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE IN 2012. THE VISUAL ACUITY STARTED TO DECLINE 6 MONTHS AFTER SURGERY. SLITLAMP EXAMINATION SHOWED THE LENS WAS DECENTERED AND TILTED, THE TEMPORAL HAPTIC WAS BENT ANTERIORLY, FIBROSIS APPEARED AT THE EDGE OF THE ANTERIOR CAPSULE, AND THERE WAS MILD OPACITY ON THE POSTERIOR CAPSULE. THE LENS WAS REPOSITIONED. SLITLAMP EXAM SHOWED LENS CENTERED, IOL HAPTIC DISTORTION HAD RESOLVED, AND POSTERIOR CAPSULE APPEARED CLEAR. ANTERIOR SEGMENT OPTICAL COHERENCE TOMOGRAPHY SHOWED THE SUPERIOR NASAL HAPTIC AND INFERIOR-TEMPORAL HAPTIC WERE IN FRONT OF THE ANTERIOR CAPSULE AND THE OTHER 2 HAPTICS WERE IN THE CAPSULAR BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242749 AKREOS ADAPTAO INTRAOCULAR LENS INTRAOCULAR LENS HQL BAUSCH + LOMB ADAPTAO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other