Synergetics 55.23.25Recalls & reported problems
Synergetics USA, Inc. · TruCurve™ Laser Probe for 25ga Surgery · 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 20841305106653), received between May 16, 2025 and May 16, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Firing Problem” (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
- Firing Problem1
Patient problems
- Eye Burn1
- Retinal Injury1
- Visual Disturbances1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 16, 2025Firing Problem; Firing Problem
A USER FACILITY IN THE NETHERLANDS REPORTED THAT THE LASER OUTPUT WAS TOO LOW. SETTINGS WERE ADJUSTED TO THE HIGHEST AND THERE WAS NO STABLE OUTPUT. AS A RESULT, THE PATIENT EXPERIENCED A RETINAL BURN.
Patient problems: Eye Burn; Retinal Injury; Visual Disturbances
MAUDE report 22038478 ↗
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- Vortex Surgical Inc. VS0135.25Vortex Surgical, Inc. · Photocoagulator And Accessories1 recall1 report
- Vortex Surgical Inc VS0125.25BVortex Surgical, Inc. · Photocoagulator And Accessories1 recall0 reports
- Vortex Surgical Inc VS0120.25Vortex Surgical, Inc. · Photocoagulator And Accessories1 recall0 reports
- Vortex Surgical Inc VS0140.25Vortex Surgical, Inc. · Photocoagulator And Accessories1 recall0 reports
- Vortex Surgical Inc VS0120.23Vortex Surgical, Inc. · Photocoagulator And Accessories1 recall0 reports
- Vortex Surgical Inc VS0130.25Vortex Surgical, Inc. · Photocoagulator And Accessories1 recall0 reports
- Vortex Surgical Inc VS0110.25Vortex Surgical, Inc. · Photocoagulator And Accessories1 recall0 reports
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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