FDA Medical Device Recalls (openFDA)
Haag-Streit USA Inc: EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).
- Recall number
- Z-1500-2017
- Recalling firm
- Haag-Streit USA Inc
- Product
- EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).
- Status
- Terminated
- Initiated
- 2017-01-05
- Posted
- not on file
- Terminated
- 2019-03-22
- Reason
- There is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow.
- Root cause
- Software design
- Action
- On January 5, 2017 the firm sent Field Safety Notice to their customers.
- Quantity
- 163 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K142423"]
- PMA numbers
- not on file
- Product code
- NFJ
- Firm FEI
- 1000136533
- Firm city
- Mason
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28