Alcon Recalls VERION Reference Units Due to Surgical Plan Errors
Alcon is voluntarily recalling 97 VERION Reference Units because unplanned arcuate lines may appear on printed or exported surgical plans.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is a voluntary medical device correction (FDA Class II) involving a documentation or output error (unplanned lines on plans) with no reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Alcon Research, Ltd. is conducting a voluntary medical device correction for 97 VERION Reference Units (Vision Planner). These units are shared with the Alcon LenSx Laser System and are used for surgical planning, imaging, and guidance during cataract surgery.
The recall was initiated after reports indicated that unplanned arcuate lines may be included on printed, saved (.pdf), or exported surgical plans. The affected units were distributed worldwide, including in the United States and numerous other countries.
Healthcare providers should identify affected units by checking the serial numbers listed in the recall notice. Alcon is managing this correction to address the software or output issue affecting the surgical planning documentation.
The recalled product
- 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…
- Manufacturer
- Alcon Research, Ltd.
- Affected units
- 97
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Serial Numbers: 1017
- 1119
- 1123
- 1125
- 1126
- 1128
- 1133
- 1135
- 1136
- 1137
- 1138
- 1139
- 1142
- 1147
- 1150
- 1153
- 1155
- 1161
- 1165
- 1168
Distribution
Distributed nationwide across the United States.
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