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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94848

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 23, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Alcon Research LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System, Part Number: 8065000399

Z-2412-2024
Recall number
Z-2412-2024
Initiated
May 23, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Alcon Research LLC
Quantity
230

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software anomaly may cause re-establishment of incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

After surgery initiation, while using surgical image guidance, if significant eye rotation/movement occurs, a software anomaly may cause re-establishment of incorrect new registration angle, range indicator will display incorrectly, which could result in incorrect placement of toric IOL axis, which could cause astigmatic error under/over correction resulting in decreased uncorrected visual acuity.

Code information

UDI-DI: 00380650003997. Software Version: 1.5. Serial Numbers: 004-0680001, 004-0680002, 004-0680003, 004-0680004, 004-0680007, 004-0680008, 004-0680017, 004-0680026, 004-0680036, 004-0680047, 004-0680048, 004-0680086, 004-0680090, 004-0680092, 004-0680096, 004-0680100, 004-0680107, 004-0680112, 004-0680120, ,004-0680127,004-0680131, 004-0680134, 004-0680140, 004-0680152, 004-0680153, 004-0680161, 004-0680163, 004-0680188, 004-0680190,004-0680203, 004-0680206, 004-0680266, 004-0680267, 004-0680271, 004-0680273, 004-0680274, 004-0680283, 004-0680288, 004-0680293, 004-0680294, 004-0680306, 004-0680311, 004-0680315, 004-0680319, 004-0680325, 004-0680334, 004-0680336, 004-0680337, 004-0680338, 004-0680339, 004-0680346, 004-0680348, 004-0680352, 004-0680362, 004-0680404, 004-0680417, 004-0680418, 005-7230003, 005-7230005, 005-7230007, 005-7230017, 005-7230019, 005-7230021, 005-7230022, 005-7230023, 005-7230031, 005-7230035, 005-7230057, 005-7230081, 005-7230085, 005-7230086, 005-7230102, 005-7230108, 005-7230109, 005-7230186, 007-4610018, 007-4610023, 007-4610030, 007-4610032, 007-4610033, 007-4610034, 007-4610037, 007-4610044, 007-4610074, 007-4610107, 007-4610112, 007-4610115, 007-4610122, 007-4610123, 007-4610124, 007-4610125, 007-4610127, 007-4610132, 007-4610138, 007-4610166, 007-4610167, 007-4610179, 007-4610181, 007-4610186, 007-4610217, 007-4610219, 007-4610220, 007-4610226, 007-4610229, 007-4610230, 007-4610262, 007-4610275, 007-4610283, 007-4610287, 007-4610288, 007-4610308, 007-4610309, 007-4610351, 007-4610355, 007-4610359, 007-4610360, 007-4610366, 007-4610394, 007-4610404, 007-4610405, 007-4610406, 007-4610409, 009-4570001, 009-4570004, 009-4570005, 009-4570007, 009-4570013, 009-4570014, 009-4570015, 009-4570016, 009-4570019, 009-4570022, 009-4570033, 009-4570035, 009-4570044, 009-4570047, 009-4570048, 009-4570049, 009-4570051,009-4570052, 009-4570053, , 009-4570054,009-4570057, 009-4570059, 009-4570060, 009-4570064, 009-4570068, 009-4570070, 009-4570072, 009-4570073, 009-4570096, 009-4570097, 009-4570099, 009-4570100, 009-4570114, 009-4570116, 009-4570125, 009-4570127, 009-4570129, 009-4570130, 009-4570136, 009-4570137, 009-4570144, 009-4570148, 009-4570149, 009-4570150, 009-4570153, 009-4570155, 009-4570156, 009-4570158, 009-4570160, 009-4570161, 009-4570167, 009-4570171, 009-4570173, 009-4570176,009-4570178, 009-4570179, 009-4570180, 009-4570183, 009-4570184, 009-4570200, 009-4570204, 009-4570207, 009-4570233, 009-4570249, 009-4570256, 009-4570259, 009-4570263, 009-4570270, 009-4570275, 009-4570278, 009-4570281, 009-4570289, 009-4570293, 009-4570294, 009-4570300, 009-4570308, 009-4570317, 009-4570320, 009-4570331, 009-4570342, 009-4570343, 009-4570350, 009-4570353, 009-4570357, 009-4570365, 009-4570368, 009-4570393, 009-4570397, 009-4570425, 009-4570431, 009-4570435, 009-4570440, 009-4570448, 009-4570449, 009-4570451, 009-4570455, 009-4570457, 009-4570459, 009-4570460, 009-4570474, 009-4570489, 009-4570508, 009-4570510, DM550021, DM550024, DM550043, DM550051, DM550054

Distribution pattern

Worldwide - US Nationwide distribution including in the states of AL, AR, CA, CO, CT, FL, GA, HI, IA, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, PA, SC, TN, TX, WA, WI, PR and the countries of Canada, Japan, France.