BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AKREOS ADVANCE ASPHERIC LENS

    MDR report key: 1841621 · Received September 16, 2010

    Report

    Report Number
    1119279-2010-00038
    Event Type
    Injury
    Date Received
    September 16, 2010
    Report Date
    August 18, 2010
    Manufacturer
    BAUSCH + LOMB
    Product Code
    HQL
    PMA / PMN Number
    P060022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETINITIS PIGMENTOSA IS ASSOCIATED WITH AGGRESSIVE CAPSULE FIBROSIS. THE POSTERIOR DISPLACEMENT OF THE IOL OPTIC IS SECONDARY TO CAPSULE CONTRACTION. QATARNEH D, HAU S, TUFT S. HYPEROPIC SHIFT FROM POSTERIOR MIGRATION OF HYDROPHOBIC ACRYLIC INTRAOCULAR LENS OPTIC. J CATARACT REFRACT SURG 2010;36-161-3.

    Description of Event or Problem · 1

    PER THE PUBLISHED LITERATURE, A PHYSICIAN REPORTS THAT A PT WITH RETINITIS PIGMENTOSA UNDERWENT UNEVENTFUL PHACOEMULSIFICATION IN THE LEFT EYE. THE PREOPERATIVE REFRACTION WAS -0.75 - 2.00 X 115. THE AXIAL LENGTH WAS 23.11 MM AND THE ACD WAS 2.57 MM. AN AKREOS ADAPT IOL WAS IMPLANTED, WITH A TARGET REFRACTION OF -0.33 D. AT 3 WEEKS POSTOPERATIVELY, THE REFRACTION WAS +1.50 - 1.00 X 090 AND THE CDVA WAS 6/18. AT 6 MONTHS, THE PT WAS AWARE OF REDUCED VISUAL ACUITY. THERE WAS SEVERE CAPSULE PHIMOSIS WITH ANTERIOR FLEXION OF THE IOL HAPTICS, HOWEVER, THERE WAS NO SPACE BETWEEN THE MARGIN OF THE ANTERIOR CAPSULOTOMY AND THE IOL AND THE REFRACTION WAS +1.00 - 0.75 X 90 (-0.37 D SHIFT). A SURGICAL ANTERIOR CAPSULOTOMY WAS PERFORMED WITH NO SUBSEQUENT CHANGE IN THE REFRACTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention