Bausch + Lomb SE5425WVRecalls & reported problems
Bausch & Lomb Incorporated · 25 ga Posterior Wide-Field Elite Pack · 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
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10757770059482), received between Feb 20, 2026 and Feb 20, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Failure to Cut” (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 16, 2026.
Reports received per month
Recalls naming this device
- Aug 8, 2018Terminated
The back cap separates from the body of the vitrectomy cutter.
Z-3273-2018 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Failure to Cut1
Patient problems
- Eye Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 20, 2026Failure to Cut
A USER FACILITY IN THAILAND REPORTED THAT DURING SURGERY THE VITRECTOMY CUTTER WAS NOT CUTTING BUT CONTINUED TO ASPIRATE. THERE WAS PATIENT CONTACT BUT NO EFFECT ON THE PATIENT. IT RESULTED IN A SURGICAL DELAY OF APPROXIMATELY 20-30 MINUTES. NORMALLY, PPV PATIENTS RECEIVE AN EYE BLOCK THAT LASTS FOR SEVERAL HOURS; HOWEVER, SUPPLEMENTAL LOCAL ANESTHESIA IS ADMINISTERED IF THE PATIENT EXPERIENCES DISCOMFORT. CONFIRMED THIS CASE ADDED ANESTHESIA TO THE PATIENT. THE SURGERY PROCEEDED SMOOTHLY WITH NO ADVERSE EFFECTS ON THE PATIENT.
Patient problems: Eye Pain
MAUDE report 24402023 ↗
Other Instrument, Vitreous Aspiration And Cutting, Ac-Powered devices
- CONSTELLATION 8065751150Alcon Laboratories, Inc. · Instrument, vitreous aspiration and cutting, ac-powered1 recall1,246 reports
- 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
- Infiniti 8065752160Alcon Laboratories, Inc. · Instrument, vitreous aspiration and cutting, ac-powered54 reports
- Bausch + Lomb SE5523WVBausch & Lomb Incorporated · Instrument, Vitreous Aspiration And Cutting, Ac-Powered1 recall4 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page