Synergetics BL5623SRecalls & reported problems
Synergetics USA, Inc. · 23ga Stellaris PC Vitrectomy Probe · Class 2
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 20841305109968), received between Jul 24, 2023 and Jul 24, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Failure to Cut” (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 18, 2026.
Most reported problems
Device problems
- Failure to Cut1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 24, 2023Failure to Cut; Failure to Cut
THE USER FACILITY IN THE UNITED KINGDOM REPORTED THE VITRECTOR WAS PRIMED CORRECTLY AND WAS SWITCHED ON WITH A CUT RATE OF 2500 BUT THE SURGEON WAS EXPERIENCING NO CUT. THEY HAD NO OTHER CUTTERS AVAILABLE SO THEY MOVED ANOTHER COMPETITORS MACHINE. THE SURGEON MANAGED TO FINISH THE CASE; HOWEVER THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY WITH VITREORETINAL CAPABILITIES AS THE CAPSULAR BAG WAS TOO DELICATE. THE PATIENT'S OUTCOME HAS BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED.
Patient problems: Insufficient Information
MAUDE report 17378737 ↗
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- Infiniti 8065752160Alcon Laboratories, Inc. · Instrument, vitreous aspiration and cutting, ac-powered54 reports
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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