Bausch + Lomb BL5525WRecalls & reported problems
Bausch & Lomb Incorporated · TSV 25ga Combined Vitrectomy Pack with AFI and Wide Field Illuminator · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00757770058181), received between May 15, 2018 and Aug 7, 2018 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (3 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Failure to Cut3
Patient problems
- No Consequences Or Impact To Patient3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 7, 2018Failure to Cut; Failure to Cut
DURING A CATARACT PROCEDURE THE CUTTER HAD DIFFICULTY CUTTING. NO MEDICAL INTERVENTION OR TREATMENT WAS REQUIRED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7757058 ↗MalfunctionAug 1, 2018Failure to Cut; Failure to Cut
DURING A CATARACT SURGERY THE VITRECTOMY CUTTER STOPPED CUTTING YET CONTINUED ASPIRATING. THERE WAS NO PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7739425 ↗MalfunctionMay 15, 2018Failure to Cut; Failure to Cut
THE VITRECTOMY CUTTER DOES NOT CUT YET CONTINUES TO ASPIRATE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7516163 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.