Bausch + Lomb SE5423WVRecalls & reported problems
Bausch & Lomb Incorporated · 23 ga Posterior Wide-Field Elite Pack · 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
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10757770059505), received between Apr 3, 2023 and Apr 3, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Decrease in Suction” (1 report).
1 FDA recall record name this device's identifier.
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.
Recalls naming this device
- Aug 8, 2018Class IITerminated
The back cap separates from the body of the vitrectomy cutter.
Z-3270-2018 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Decrease in Suction1
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.
InjuryApr 3, 2023Decrease in Suction; Decrease in Suction
IT WAS REPORTED BY THE USER FACILITY THAT THE CUTTER''S ASPIRATION WAS NOT WORKING. ASPIRATION STOPPED AND COMPLETE REMOVAL OF THE LENS WAS NOT POSSIBLE, THEREFORE A SECONDARY SURGERY WAS REQUIRED. THE SECOND SURGERY WENT FINE, WITH NO ISSUES REMOVING THE REMAINING LENS FRAGMENT. SURGERY WAS A SUCCESS.
Patient problems: Insufficient Information
MAUDE report 16664434 ↗
Other Instrument, Vitreous Aspiration And Cutting, Ac-Powered devices
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- CONSTELLATION 8065753041Alcon Laboratories, Inc. · Instrument, vitreous aspiration and cutting, ac-powered503 reports
- Centurion, OZil 8065751761Alcon Laboratories, Inc. · Instrument, vitreous aspiration and cutting, ac-powered475 reports
- UNITY 00380650002969Alcon Laboratories, Inc. · Instrument, Vitreous Aspiration And Cutting, Ac-Powered271 reports
- Ozil 8065750469Alcon Laboratories, Inc. · Instrument, vitreous aspiration and cutting, ac-powered261 reports
- Bausch + Lomb SE5523WVBausch & Lomb Incorporated · Instrument, Vitreous Aspiration And Cutting, Ac-Powered1 recall4 reports
- Infiniti 8065752160Alcon Laboratories, Inc. · Instrument, vitreous aspiration and cutting, ac-powered54 reports
- Bausch + Lomb SE5525WVBausch & Lomb Incorporated · Instrument, Vitreous Aspiration And Cutting, Ac-Powered1 recall2 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 · each recall links to the FDA recall notice
- 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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