Bausch + Lomb BL3420SRecalls & reported problems
Bausch & Lomb Incorporated · MICS Straight Phaco Needle · Class 2
Data updated Oct 16, 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 10757770058713), received between Oct 3, 2023 and Jan 6, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Partial 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Partial Blockage1
- Particulates1
Patient problems
- Eye Burn1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 6, 2026Partial Blockage
THE USER FACILITY REPORTED A WOUND BURN AT THE MAIN INCISION PORT DURING SCULPT WHERE 1X 10-0 VICRYL WAS USED TO CLOSE. BL3420S IS THE PHACO TIP AND WAS DISPOSED AND ISN¿T AVAILABLE FOR RETURN. THE DOCTOR STATED, IT COULD HAVE BEEN A CLOGGED TIP BUT WAS NOT CERTAIN.
Patient problems: Eye Burn
MAUDE report 23980960 ↗MalfunctionOct 3, 2023Particulates; Particulates
A USER FACILITY IN AUSTRALIA REPORTED THAT THE SURGEON THOUGHT HE SAW SOMETHING COME FROM THE TIP OR HANDPIECE INTO THE PATIENT''S EYE. THE FRAGMENT WAS NO LONGER VISIBLE. THE NEEDLE AND HANDPIECE WERE CHANGED AND A NEW SLEEVE WAS APPLIED TO THE PHACO TIP. THE NEW HANDPIECE TUNED AND THE SURGERY WAS COMPLETED WITHOUT FURTHER INCIDENT. THE NEEDLE AND SLEEVE ARE NOT AVAILABLE FOR RETURN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17861970 ↗
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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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