Bausch + Lomb SE5525MVBRecalls & reported problems
Bausch & Lomb Incorporated · 25 ga. Bi-Blade Vitreous Cutter Combined Mid-Field Stellaris Elite Pack · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10757770059789), received between Dec 20, 2022 and Dec 20, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).
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.
Most reported problems
Device problems
- Insufficient Device Problem Information2
Patient problems
- Endophthalmitis2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 20, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
A USER FACILITY IN JAPAN REPORTED A CASE OF POST-OP ENDOPHTHALMITIS ON A PATIENT. THE CAUSALITY IS UNKNOWN. IT WAS REPORTED THAT IN ADDITION TO THE DISPOSABLE PACK, THE CUSTOMER MAY HAVE POSSIBLY USED A CUTTER OR VALVE, BUT THIS WAS NOT CONFIRMED. NO OTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Endophthalmitis
MAUDE report 16015735 ↗InjuryDec 20, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
A USER FACILITY IN JAPAN REPORTED A CASE OF POST-OP ENDOPHTHALMITIS ON A PATIENT. THE CAUSALITY IS UNKNOWN. IT WAS REPORTED THAT IN ADDITION TO THE DISPOSABLE PACK, THE CUSTOMER MAY HAVE POSSIBLY USED A CUTTER OR VALVE, BUT THIS WAS NOT CONFIRMED. NO OTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Endophthalmitis
MAUDE report 16015734 ↗
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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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