FDA Device recall Z-1500-2017

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

FDA Device
Class II
terminated
Published 2017-03-29

On 2017-03-29 the FDA classified a Class II recall of EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs) by Haag Streit Usa, citing there is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1500-2017
Classification	Class II
Status	terminated
Initiated	2017-01-05
Published	2017-03-29
Last updated	2026-09-13 11:54 UTC
Company	Haag Streit Usa
Distribution	US

Product

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.

Identifiers

code_info	Model # 7220374 EyeSuite DICOM Option, 7220379 DICOM License .BQ 900 LED S/N: 3682 BQ LET Table S/N: 10038 BX 900… 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. Oc

code_info

Model # 7220374 EyeSuite DICOM Option, 7220379 DICOM License .BQ 900 LED S/N: 3682 BQ LET Table S/N: 10038 BX 900…

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. Oc

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1500-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.