Reported Jul 24, 2024 · Ongoing

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

Alcon Research LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Alcon Research LLC · Aspex Facility · Fort Worth, TX · 76134-2099

Is this the product you have?

Surgical Image Guidance Functionality, software used with NGENUITY 3D Visualization System
Part Number8065000399

Lot codes and dates: UDI-DI00380650003997
Software Version1.5
Serial Numbers
230 of 230 codes
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
Amount recalled: 230

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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By hazard

Medical device recalls

Other recalls from Alcon Research LLC

13 in total.

Where it was distributed

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