VERION Reference Unit — Class II medical device recall Z-1394-2016
Terminated recall by Alcon Research, Ltd., reported 2016-04-20, distributed nationwide. Alcon is conducting a voluntary medical device correction of all VERION Reference Units (Vision Planner) that
| Recall number | Z-1394-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Research, Ltd., Fort Worth, TX, United States |
| Recall initiated | 2016-03-01 |
| Classified | 2016-04-14 |
| Reported by FDA | 2016-04-20 |
| Terminated | 2017-04-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BR, CH, CL, CN, CO, CR, CZ, DK, DO, EC, EG, ES, FR, GB, GR, HU, IN, IT, JP, KR, MX, MY, NI, NL, NO, PA, PH, PT, RO, SG, SK, SV, TH, TR, TT, TW, ZA |
| Quantity | 97 units |
| Serial numbers | 1017, 1119, 1123, 1125, 1126, 1128, 1133, 1135, 1136, 1137, 1138, 1139, 1142, 1147, 1150, 1153, 1155, 1161, 1165, 1168, 1172, 1178, 1181, 1182, 1183 and 72 more |
Product
VERION Reference Unit (Vision Planner) Product Usage: The VERION Image Guided system is an advanced surgical planning, imaging and guidance technology designed to provide greater accuracy and efficiency during cataract surgery. It allows eye surgeons to capture a high-resolution, diagnostic reference image of the patients eye pre-operatively, quickly determine an optimized surgical plan that enables surgeons to see all inclusions and alignment in real-time.
Reason for recall
Alcon is conducting a voluntary medical device correction of all VERION Reference Units (Vision Planner) that are shared with the Alcon LenSx Laser System after receiving reports concerning the inclusion of unplanned arcuates on printed, saved (.pdf) or exported surgical plans.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1394-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.