EyeSuite i.8.2.1.0 Software for ophthalmic use recall
EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).
Why was EyeSuite i.8.2.1.0 Software for ophthalmic use recalled?
There is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).
- Recalling firm
- Haag-Streit USA Inc
- Quantity
- 163 units
- Distribution
- US Nationwide distribution.
- Recall date
- March 29, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)