Bausch + Lomb BL3118Recalls & reported problems
Bausch & Lomb Incorporated · 1.8mm (GUM) Micro Coaxial Sleeve · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10757770057389), received between Apr 6, 2022 and Sep 12, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Particulates” (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 18, 2026.
Most reported problems
Device problems
- Particulates2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 12, 2023Particulates; Particulates
IT WAS REPORTED BY THE USER FACILITY IN THE UNITED KINGDOM THAT A PARTICLE OF SILICON WAS ON THE END OF THE SLEEVE AND ENTERED THE PATIENT''S EYE. NO HARM TO THE PATIENT AS THE PARTICLE WAS IDENTIFIED AND REMOVED. THERE WAS AN INCREASE IN DURATION TO SURGERY OF 0-15 MINUTES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17731447 ↗MalfunctionApr 6, 2022Particulates; Particulates
A USER FACILITY IN (B)(6) REPORTS THAT DURING SURGERY, THE SURGEON FOUND A MICROSCOPIC TRANSPARENT FILAMENT IN THE PATIENT¿S EYE. THE SURGEON ASSERTS THAT THE TRANSPARENT FILAMENT CAME FROM THE STERILE MEDICAL DEVICE. THE FILAMENT WAS EXTRACTED. THE PATIENT OUTCOME IS UNKNOWN.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 14027995 ↗
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- Alcon 8065752201Alcon Laboratories, Inc. · Unit, phacofragmentation1 recall386 reports
- Alcon 8065752200Alcon Laboratories, Inc. · Unit, phacofragmentation1 recall366 reports
- Constellation, Ultravit, 25+, TotalPlus, EdgePlus 8065751767Alcon Laboratories, Inc. · Unit, phacofragmentation2 recalls302 reports
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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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