VisuMax Software Recall for Incorrect Corneal Cut Type During Suction Loss
Carl Zeiss Meditec is recalling VisuMax software version 2.10.13 because a defect may cause a cap cut instead of a flap cut if suction is lost during treatment.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect that results in an unintended surgical procedure (cap cut instead of flap cut). While no injuries are reported in the source text, the risk of harm from an incorrect surgical cut in the eye classifies this as a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Carl Zeiss Meditec, Inc. is recalling 66 units of the VisuMax Femtosecond Laser System equipped with Software Version 2.10.13 and the activated Software-Module ReLEx (SMILE) option. The affected devices are used for small incision lenticule extraction (SMILE) to treat myopia. The recall covers units distributed nationwide in the United States.
The recall is due to a software defect that occurs if suction is lost during Phase 2 of the treatment (between 10% and 100% of the lower lenticule cut). In this specific scenario, the software offers a flap cut option, but due to the defect, it performs a cap cut instead if the user proceeds. Suction loss can occur in phases 1 through 5, but the software issue specifically affects Phase 2.
Healthcare providers should check their device serial numbers against the list provided in the official recall notice to determine if their unit is affected. Consumers who have undergone SMILE surgery with these specific software versions should contact their eye care provider for guidance. No specific instructions for immediate consumer action are provided in the source text beyond identifying affected units.
The recalled product
- Product
- VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunction with the VisuMax Femtosecond Laser System for Refractive Correction. Catalog Number 0000000-1345-518 Product Usage: The VisuMax Femtosecond Laser is a precision…
- Manufacturer
- Carl Zeiss Meditec, Inc.
- Affected units
- 66
Distribution
Distributed nationwide across the United States.
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