ARTEVO 750/850 6649Recalls & reported problems
Carl Zeiss Meditec AG · ARTEVO 750/850 is a surgical microscope intended for the magnification of the surgical area and for the visualization in surgical procedures in the field of ophthalmology. · Class 1
Data updated Oct 16, 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 04049539066497), received between May 30, 2025 and May 30, 2025 — classified as 1 injury.
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Phototoxicity1
- Visual Impairment1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT A PATIENT DEVELOPED PHOTOTOXICITY FROM A VITRECTOMY SURGERY INVOLVING THE USE OF AN ARTEVO 750 / 850. THE CASE WAS ABOUT 1:45 HOURS IN LENGTH AND NO UNUSUAL MEDICATIONS WERE USED. THE PATIENT HAD A STRAIGHTFORWARD VITRECTOMY WITHOUT COMPLICATIONS OR EVEN CONTACT WITH THE MACULAR SURFACE. HOWEVER, ABOUT 1 MONTH POSTOP, THE PATIENT HAS PARACENTRAL VISION CHANGES AS WELL AS CHANGES TO THE ELLIPSOID ZONE ON OCULAR COHERENCE TOMOGRAPHY.
Patient problems: Phototoxicity; Visual Impairment
MAUDE report 22115938 ↗
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- OPMI Lumera 700 6634Carl Zeiss Meditec AG · Microscope, Operating & Accessories, Ac-Powered, Ophthalmic2 reports
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- PROVEO 8 Optics Carrier 000000000010448800Leica Microsystems (Schweiz) AG · MICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC1 report
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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