BEUDAMED
    FDA Enforcement Class II Ongoing

    Pentacam HR REF 70900. Used to image the anterior segment of the eye.

    Recall: Z-1674-2022 · Reported September 7, 2022

    Enforcement

    Recall Number
    Z-1674-2022
    Event ID
    90661
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Oculus Optikgeraete GMBH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 7, 2022
    Initiation Date
    July 8, 2022
    Classification Date
    September 1, 2022
    Address
    Munchholzhauser Str. 29, Wetzlar, N/A, Germany

    Description

    Pentacam HR REF 70900. Used to image the anterior segment of the eye.

    Reason

    Due to a software issue, IOL calculator printout often does not accurately reflect the alignment axis and incision position when planning toric IOLs

    Code Info

    Software version: 1.26r26 and 1.26r27 Model Number: 70900 UDI-DI Code: 04049584000026 Serial Numbers: 70900 0574 8160 70900 0925 0240 70900 0995 2250 70900 1664 8130 70900 1995 2250 70900 3451 7060 70900 3795 2250 70900 3965 1270 70900 4041 7010 70900 4172 2110 70900 4795 2250 70900 6234 7150 70900 7552 1160 70900 7952 1180 70900 8804 6140 70900 8813 3140 70900 9142 0121 70900 9695 2250 70900 9795 2250

    Distribution

    U.S.: AL, AR, AZ, CAQ, CO, CT, FL, GA, HI, IA, ID, IL, KS, KY, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, and WY O.U.S.: N/A

    Quantity

    19 systems with affected software