Navilas® Laser System 577sRecalls & reported problems
OD-OS GmbH · The Navilas® Laser System 577s is a laser photocoagulator with an integrated digital fundus camera. The Navilas® Laser System 577s combines imaging technologies (fundus live imaging, and infra-red imaging) with established laser photocoagulation treatment methods by providing the doctor a system for imaging and treatment planning prior to the photocoagulation. · Class 2
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 04260284390013), received between Apr 1, 2026 and Apr 1, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
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
- Insufficient Device Problem Information1
Patient problems
- Retinal Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 1, 2026Insufficient Device Problem Information
ON (B)(6) 2026, THE CUSTOMER REPORTED HEARING A STRANGE "STATIC NOISE" COMING FROM THE LASER OPTICAL HEAD OF A NAVILAS 577S LASER SYSTEM DEVICE (SN (B)(6)) LASTING APPROXIMATELY 5 MINUTES BEFORE DISAPPEARING. SUBSEQUENTLY, THE CUSTOMER PERFORMED A TREATMENT SESSION, AND UPON REVIEW OF THE TREATMENT DOCUMENTATION, THE PHYSICIAN OBSERVED THE LASER FIRING WITHIN THE SET EXCLUSION BOUNDARY RATHER THAN THE INTENDED TREATMENT ZONE. THE SYSTEM'S LOG FILES FROM THE DATE OF THE INCIDENT SHOWED MULTIPLE WARNINGS RELATED TO THE AIMING BEAM POSITION NOT BEING VERIFIED, INCLUDING: · "AIMING BEAM POSITION COULD NOT BE VERIFIED. IMPROVE AIMING BEAM VISIBILITY." "SYSTEM IS UNABLE TO CONFIRM AIMING BEAM POSITION." · "REJECTED SPOT APPLICATION DUE TO MISSING AIMING BEAM POSITION." THE USER ELECTED TO PROCEED WITH THE LASER TREATMENT DESPITE THE WARNING MESSAGES. THE TREATMENT IMAGES LATER SHOWED SPOT OFFSET IN TWO TREATMENT PATTERNS, INCLUDING SOME SPOTS WITHIN THE EXCLUSION AREA. NO BURNS WERE VISIBLE IN THE CENTRAL MACULA, AND THE FOVEA WAS NOT AFFECTED. THE PHYSICIAN REPORTED THAT NO SIGNIFICANT VISION LOSS WAS OBSERVED NOR IS EXPECTED, AND THE PATIENT'S PROGNOSIS IS GOOD. SERVICE INSPECTIONS WE
Patient problems: Retinal Injury
MAUDE report 24754074 ↗
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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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