Z-1500-2017Class II

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

Name: Z-1500-2017 EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs)
Creator: Haag-Streit USA Inc
Published: 2017-01-05
License: https://open.fda.gov/license/

Haag-Streit USA Inc / initiated 2017-01-05 / Terminated / root cause: software

FDA source

Haag-Streit USA Inc began a recall of EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs) on 2017-01-05. FDA classified it as Class II and gives the reason as "There is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1500-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-05
Posted: 2017-03-20
Terminated: 2019-03-22
Recalling firm: Haag-Streit USA Inc
Product: EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).
Product code: NFJ System, Image Management, Ophthalmic
Reason for recall: There is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow.
Root cause tag: software
FDA root cause: Software design
Action: On January 5, 2017 the firm sent Field Safety Notice to their customers.
Quantity in commerce: 163 units
Distribution: US Nationwide distribution.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1500-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1500-2017	Class II	Terminated	Voluntary: Firm initiated	2017-03-29	2017-03-20

Product code NFJ

K142423Class IIEyeSuite ImagingHaag-Streit AG / cleared 2014-09-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)