Bausch + Lomb BL5520WRecalls & reported problems
Bausch & Lomb Incorporated · 20ga Combined Vitrectomy Pack with AFI and Wide Field Illuminator · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00757770058167), received between Jul 11, 2018 and Jul 11, 2018 — classified as 1 malfunction.
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 16, 2026.
Most reported problems
Device problems
- Failure to Cut1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 11, 2018Failure to Cut; Failure to Cut
USER FACILITY IN (B)(6) REPORTED THAT DURING CORE VITREOUS REMOVAL, THE SURGEON NOTICED THE CUTTER FAILED TO BE CUTTING THOUGH STILL ASPIRATING. CUTTER WAS REMOVED FROM THE EYE AND TESTED IN GALLIPOT AT 1000CPM AND AGAIN AT 5000CPM. HOWEVER SURGEON REPORTED THAT THE CUTTER WAS STILL NOT CUTTING. A NEW PACK WAS OPENED AND SURGERY WAS COMPLETED SUCCESSFULLY WITH NO EFFECT ON THE PATIENT.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 7679206 ↗
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
- 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
- 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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