ModerateClass IITerminated

FDA Devices recall · Reported December 25, 2019

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 ophthalmic surgical laser designed for the creation of incisions in the cornea. The VisuMax Femtosecond Laser is indicated for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia. This d

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on December 25, 2019. Severity: Moderate. Recall number: Z-0680-2020.

Q: Where was the recalled product distributed?

Distribution: US nationwide distribution..

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-0680-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

VisuMax devices with software version 2.10.13 and activated SW-Module ReLEx (SMILE) option may experience a software issue. In case of a suction loss during treatment the softwar…

Recall #: Z-0680-2020
Affected scope: 66 units
Initiated: December 6, 2018

Compiled from official public sources by the editorial team. · Updated July 2026

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Carl Zeiss Meditec, Inc. recalled VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used… - a moderate-severity action.

VisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used… was recalled by Carl Zeiss Meditec, Inc. in December 25, 2019. Reason: VisuMax devices with software version 2.10.13 and activated SW-Module ReLEx (SMILE) option may experience a s…. Check the official notice for the remedy. Verify recall #Z-0680-2020 with the FDA Devices before acting.

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The recall

Carl Zeiss Meditec, Inc. issued this moderate-severity FDA Devices recall-VisuMax devices with software version 2.10.13 and activated SW-Module ReLEx (SMILE) option may experience a s….

Moderate
severity level: 66 units
affected scope: Class II
classification: December 25, 2019
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0680-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-0680-2020) was formally reported on December 25, 2019, with the manufacturer initiating the action on December 6, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Carl Zeiss Meditec, Inc. is listed as the recalling firm, operating out of Dublin, CA. Federal records list the affected scope as 66 units.

The documented reason for this recall is: VisuMax devices with software version 2.10.13 and activated SW-Module ReLEx (SMILE) option may experience a software issue. In case of a suction loss during treatment the software allows the user to choose the option i… Distribution data in the federal record shows the product reached: US nationwide distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

66 units

Related Recalls

3 from same agency

Product description

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 ophthalmic surgical laser designed for the creation of incisions in the cornea. The VisuMax Femtosecond Laser is indicated for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia. This device is intended for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia >=-1.00 D to <=-8.00 D, with <=-0.50 D cylinder and MRSE <=-8.25 D in the eye to be treated in patients who are 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change of <=0.50 D MRSE.

Reason for recall

VisuMax devices with software version 2.10.13 and activated SW-Module ReLEx (SMILE) option may experience a software issue. In case of a suction loss during treatment the software allows the user to choose the option immediate restart or restart treatment. Suction loss can occur in phase 1 through phase 5. The software defect refers to Phase 2 (between 10% and 100% of lower lenticule cut) only. The software offers a flap cut, but due to the software issue it performs a cap cut instead of a flap cut if the user proceeds.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-0680-2020
Date reported	December 25, 2019
Date initiated	December 6, 2018
Recalling firm	Carl Zeiss Meditec, Inc.
Firm location	Dublin, CA
Affected scope	66 units
Distribution	US nationwide distribution.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

66 units units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-0680-2020) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on December 25, 2019. Severity: Moderate. Recall number: Z-0680-2020.

Where was the recalled product distributed? ▼

Distribution: US nationwide distribution..

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-0680-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 25, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.