Bausch + Lomb BL5114ARecalls & reported problems
Bausch & Lomb Incorporated · 1.8mm Premium Vacuum Phaco Pack with MICS Angled Needle · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00757770057702), received between Aug 17, 2017 and May 22, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Complete Blockage” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Complete Blockage1
- Particulates1
Patient problems
- Eye Burn1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 22, 2025Complete Blockage; Complete Blockage
THE USER FACILITY IN UNITED KINGDOM REPORTED THAT ON A CASE WITH A PARTICULARLY DENSE CATARACT, TIP BLOCKAGE POSSIBLY OCCURRED CAUSING ASPIRATION TO PAUSE MOMENTARILY. A SMALL CORNEAL BURN RESULTED, REQUIRING A SUTURE AND DELAYING THE SURGERY UP TO 15 MINUTES. A BAUSCH AND LOMB REPRESENTATIVE WAS PRESENT DURING THE OPERATION AND INSTRUCTED SURGEON ON HOW TO PREVENT ANY BURN IF TIP BLOCKS, AND ADJUSTED PHACO SETTINGS.
Patient problems: Eye Burn
MAUDE report 22069915 ↗MalfunctionAug 17, 2017Particulates; Particulates
A REPORT FROM A USER FACILITY IN THE (B)(4) STATED THAT HAIR LIKE STRANDS APPEARED TO COME OUT FROM THE PHACO TIP. THE STRANDS APPEARED RIGHT AT THE START OF SURGERY WHEN THE SURGEON STARTED IN THE SCULPT PHASE AND THEY WERE REMOVED WITH CAPSULORHEXIS FORCEPS. THE PACK, HANDPIECE AND TROLLEY WERE REPLACED. THERE WAS NO OTHER INCIDENCE DURING THE LIST.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6802194 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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