VISUMAX VISUMAX 800 or 09511Recalls & reported problems
Carl Zeiss Meditec AG · The VISUMAX is a femtosecond laser. It generates a beam of ultra-short laser pulses which are guided through the aperture in the treatment objective . The optical system focuses the laser beam into the corneal tissue. The VISUMAX Femtosecond Laser is indicated for use in small incision lenticule extraction (SMILE) for the reduction or elimination of myopia with or without astigmatism • for spherical refractive error (in minus cylinder format) from -1.00 diopters through -10.00 diopters, • for cylinder from -0.75 diopters through -3.00 diopters, • when refraction spherical equivalent is no greater in magnitude than 10.00 diopters, in patients 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in sphere and cylinder of lower or equal 0.50 D in magnitude. · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04049471095111), received between Apr 16, 2024 and Apr 16, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (1 report).
1 other recall cover devices cleared under the same FDA submission (P150040); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Loss of Vision1
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 16, 2024Use of Device Problem; Use of Device Problem
PATIENT TREATED WITH VISUMAX SMILE PRO WAS NEGATIVELY IMPACTED (POOR VISUAL ACUITY) AFTER SURGEON DECIDED TO PROCEED TO REMOVE THE LENTICULE IN THE RIGHT EYE DESPITE THE EXISTENCE OF INCOMPLETE CUTS (BLACK SPOTS). A DOUBLE PLANE WAS CREATED AND THE LENTICULE COULD NOT BE REMOVED COMPLETELY.
Patient problems: Loss of Vision; Visual Impairment
MAUDE report 19121586 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P150040. One submission often covers many models, so check the product and lot details in each record.
- Z-0680-2020 · Dec 6, 2018 · TerminatedVisuMax Software Version 2.10.13 with activated Software-Module ReLEx (SMILE) option used in conjunction with the VisuMax Femtosecond Laser System for Refractive Correction. Cat
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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