BEUDAMED
    FDA Enforcement Class II Terminated

    EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).

    Recall: Z-1500-2017 · Reported March 29, 2017

    Enforcement

    Recall Number
    Z-1500-2017
    Event ID
    76405
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Haag-Streit USA Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 29, 2017
    Initiation Date
    January 5, 2017
    Classification Date
    March 20, 2017
    Termination Date
    March 22, 2019
    Address
    3535 Kings Mills Rd, Mason, OH, 45040-2303, United States

    Description

    EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).

    Reason

    There is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow.

    Code Info

    Model # 7220374 EyeSuite DICOM Option, 7220379 DICOM License .BQ 900 LED S/N: 3682 BQ LET Table S/N: 10038 BX 900 LED w/Digital EyeSuite S/N: 10016 CM 900 S/N: 354 & 491. IM 900 / BQ 900 LED S/N: 919, 5036, 1136, 3146, 3147, 3148, 3150, 560, 3131, 2412 & 3011. License Only S/N: 03011, 3210, BP5P922, 5617, 724, 1406, 3204, 2306, 2314, 2514, 3087, 1246, 2395 & 1063. Lenstar S/N: 167, 285, 332, 416, 469, 656, 878, 1134, 1136, 1197, 1313, 1332, 1607, 2026, 2029, 2030, 2126, 2127, 2128, 2308, 2342, 2343, 2346, 2347, 2349, 2350, 2352, 2353, 2355, 2362, 2387, 2388, 2393, 2686, 2758, 2871, 2901, 2976, 3078, 3084, 3170, 3254, 20213, 3202, 579, 1298, 2055, 2118, 2737, 221, 485, 539, 639, 999, 1246, 2022, 2051, 2274, 2691, 2755, 2756, 2757, 2836, 2908, 3252, 3542, 3753, 3820, 3821, 3901, 3904, 3908, 3946, 3950, 20311, 20111, 20176, 20149 & 10. Octopus 300 S/N: 4242, 3330, 3735 & 1506. Octopus 600 S/N: 135, 246, 433, 434, 443, 708, 709, 710, 955, 956, 957, 958 & Demo. Octopus 900 S/N: 2968, 1784, 2023, 2140, 2237, 2883, 2884, 2886, 2967, 3010, 3286, 3753, 1784, 1286, 1937, 2763, 2778, 3746, 3139, 2813, 1143, 1239, 1287, 2233, 2373, 2406, 2566, 2567, 2780, 2889, 2926, 3200, 2890, 2024, 1582, 1619, 1647, 2174, 2586, 2624, 3006, 3009, 3011 & 3372.

    Distribution

    US Nationwide distribution.

    Quantity

    163 units