Bausch + Lomb BL3170Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00757770480852), received between Jan 11, 2017 and Jan 5, 2026 — classified as 10 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Particulates” (31 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

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 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 23958121 ↗
• InjuryAug 7, 2025Energy Output Problem; Energy Output Problem

  THE USER FACILITY IN ITALY REPORTED THAT THERE WAS UNCONTROLLED ULTRASOUND DISCHARGE DURING CATARACT SURGERY. AS SOON AS THE SURGEON BEGAN USING THE ULTRASOUND, A SUDDEN DISCHARGE APPEARED TO BE RELEASED, EXCEEDING THE MAXIMUM ULTRASOUND SETTING (28), SHATTERING THE LENS INTO MANY PIECES. THE NEXT DAY, VITREORETINAL SURGERY WAS PERFORMED ON THE PATIENT TO RECOVER THE NUCLEUS PIECES IN THE POSTERIOR SEGMENT OF THE EYE. NO FURTHER INFORMATION ABOUT THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 22739428 ↗
• MalfunctionDec 20, 2024Particulates; Particulates

  THE MALE PATIENT BORN IN 1953, SAW THE SURGEON FOR A CONSULTATION ON (B)(6) 2025. THE PATIENT STILL HAS METAL MICROPARTICLES ON THE IRIS WITHOUT ANY INFLAMMATORY REACTION. NO INFLAMMATORY REACTION HAS BEEN OBSERVED IN THE VITREOUS BODY EITHER. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 20989968 ↗
• MalfunctionDec 20, 2024Particulates; Particulates

  ADDITIONAL INFORMATION RECEIVED, TO THE CUSTOMERS KNOWLEDGE THE PARTICLES HAVE NOT BEEN REMOVED FROM THE PATIENTS EYE.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 20989805 ↗
• MalfunctionDec 20, 2024Particulates; Particulates

  THE MALE PATIENT BORN IN 1953, SAW THE SURGEON FOR A CONSULTATION ON (B)(6) 2025. THE PATIENT STILL HAS METAL MICROPARTICLES ON THE IRIS WITHOUT ANY INFLAMMATORY REACTION. NO INFLAMMATORY REACTION HAS BEEN OBSERVED IN THE VITREOUS BODY EITHER. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 20989760 ↗
• InjuryNov 26, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE USER FACILITY REPORTED A WOUND BURN DURING A PROCEDURE. THE SURGEON USED ONE SUTURE TO CLOSE AND THE NEXT DAY THE PATIENT WAS DOING FINE.

  Patient problems: Eye Burn

  MAUDE report 20779152 ↗
• MalfunctionOct 29, 2024Particulates; Particulates

  A USER FACILITY IN FRANCE REPORTED THAT A MILKY LIQUID WAS RELEASED FROM THE HANDPIECE. THE ULTRASOUND AND SUCTION WAS FAULTY. THE HANDPIECE WAS CHANGED AND THE PROCEDURE CONTINUED. THERE WAS NO REPORTED PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20557623 ↗
• MalfunctionSep 13, 2024Particulates; Particulates

  A USER FACILITY REPORTED THAT DURING SURGERY WHEN THE CATARACT WAS BEING REMOVED, A BLACK SUBSTANCE WAS NOTICED IN THE EYE. IT WAS CONFIRMED THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT YET RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20212623 ↗
• MalfunctionAug 21, 2024Particulates; Particulates

  THE USER FACILITY IN SWITZERLAND REPORTED THEY PERFORMED A PHACOEMULSIFICATION USING THE DIVIDE AND CONQUER TECHNIQUE. AFTER THE PHACO TIP WAS INSERTED INTO THE ANTERIOR CHAMBER AND THE IRRIGATION ASPIRATION BEGUN, A FINE, GLITTERING PARTICLE, MOST LIKELY METAL DUST, ENTERED THE ANTERIOR CHAMBER. THIS OCCURRED AFTER THE PHACO TIP HAD ALREADY BEEN RINSED FOR CALIBRATION AND THEN RINSED AGAIN. THE PARTICLE WAS UNABLE TO BE RETRIEVED USING FORCEPS, HOWEVER, THE PHACOEMULSIFICATION WAS CONTINUED. DURING THE DIGGING, THE FOREIGN BODY WAS ASPIRATED. AT THE END OF OPERATION, NO FOREIGN BODY RESIDUE COULD BE PERCEIVED. THERE WAS NO ADVERSE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20023455 ↗
• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A USER FACILITY IN AUSTRALIA REPORTED A PATIENT BURN DURING SURGERY. THE PATIENT RECEIVED ONE SUTURE TO CLOSE THE WOUND AND BASIC UNKNOWN POST-OP MEDICATION. THE PHYSICIAN STATED IT WAS UNCLEAR WHAT WENT WRONG RESULTING IN THE PATIENT BURN AND BELIEVED THAT INITIALLY THE TIP OF THE HANDPIECE WAS NOT ON CORRECTLY. THE TIP WAS REPLACED BUT THE ISSUE CONTINUED. THE PHACO HANDPIECE WAS THEN REPLACED ALONG WITH A NEW TIP. PATIENT OUTCOME IS CURRENTLY UNKNOWN.

  Patient problems: Eye Burn

  MAUDE report 19047339 ↗
• MalfunctionJan 2, 2024Particulates; Particulates

  THE USER FACILITY IN FRANCE REPORTED THAT DURING SURGERY A WHITE MILKY LIQUID WAS COMING OUT OF THE HANDPIECE AND THERE WAS POOR ASPIRATION. THERE WERE NO REPORTED PATIENT CONSEQUENCES. THE PHARMACIST INDICATED THAT THE GUIDELINES RECOMMEND USING WARM DISTILLED SOFTENED WATER AND THE ESTABLISHMENT USES COLD WATER (AT ROOM TEMPERATURE, I.E. AROUND 20°C) NOT NECESSARILY SOFTENED . A STERILIZATION CYCLE AT 134°C FOR 18 MINUTES IS ALSO RECOMMENDED AND THE USER FACILITY DOES THIS FOR 18 MINUTES. THE PATIENT WAS PRESCRIBED PREVENTATIVE ANTIBIOTICS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18426419 ↗
• MalfunctionDec 21, 2023Particulates; Particulates

  THE USER FACILITY IN FRANCE REPORTED THAT MILKY FLUID WAS RELEASED FROM THE HANDPIECE DURING SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18378224 ↗
• MalfunctionDec 1, 2023Particulates; Particulates

  THE USER FACILITY IN FRANCE REPORTED THAT MILKY FLUID WAS RELEASED FROM THE HANDPIECES DURING THE PROCEDURE. THIS REPORT IS FOR THE FIRST HANDPIECE.

  Patient problems: Insufficient Information

  MAUDE report 18252206 ↗
• MalfunctionDec 1, 2023Particulates; Particulates

  THE USER FACILITY IN FRANCE REPORTED THAT MILKY FLUID WAS RELEASED FROM THE HANDPIECES DURING THE PROCEDURE. THIS REPORT IS FOR THE SECOND HANDPIECE.

  Patient problems: Insufficient Information

  MAUDE report 18251306 ↗
• InjuryNov 3, 2023Particulates; Particulates

  ADDITIONAL INFORMATION WAS RECEIVED AFTER THE INITIAL REPORT. THE PATIENT HAD A FUNCTIONAL LOSS OF THE EYE: MONOCULAR. THE POST-OPERATIVE ENDOPHTHALMITIS WAS TREATED WITH CORTICOSTEROIDS.

  Patient problems: Endophthalmitis

  MAUDE report 18067618 ↗
• InjuryNov 1, 2023Suction Problem; Noise, Audible; Suction Problem; Noise, Audible

  THE USER FACILITY REPORTED DURING PRE-PHACO AND SCULPT THE HANDPIECE DIDN¿T FEEL LIKE IT WAS ASPIRATING AND MADE A UNIQUE NOISE, SIMILAR TO THE TIP NOT BEING FULLY TIGHTENED. WHEN CHECKED, THE TIP WAS TIGHT. THIS PATIENT RECEIVED ONE SUTURE TO CLOSE THE WOUND AND BASIC POST-OP MEDICATION.

  Patient problems: Eye Burn

  MAUDE report 18047899 ↗
• MalfunctionOct 6, 2023Particulates; Particulates

  THE USER FACILITY IN SINGAPORE REPORTED THAT THE SURGEON WAS DOING A CATARACT DEBULKING PROCEDURE BEFORE STARTING IN-SITU CHOP, WHEN ONE METALLIC PIECE OF FOREIGN BODY FLEW OUT FROM THE PHACO HANDPIECE INTO PATIENT¿S EYE. THE SURGEON RETRIEVED THE PARTICULATE AND THERE WAS NO PARTICULATE LEFT BEHIND IN THE EYE AT THE END OF PROCEDURE. THE NURSE FLUSHED THE HANDPIECE IN A GALLIPOT AND SAW MORE METAL PIECES IN IT. THE SURGEON CHANGED HANDPIECES, WITH NO IMPACT OR INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17887479 ↗
• MalfunctionJun 28, 2023Particulates; Particulates

  ADDITIONAL INFORMATION: THE PARTICLE WAS RETRIEVED FROM THE "PATIENT'S" EYE USING FORCEPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17217966 ↗
• InjuryJan 18, 2023Particulates; Particulates

  THE USER FACILITY IN THE UNITED KINGDOM REPORTED THAT A WHITE MATERIAL WAS OBSERVED IN THE PHACO TIP DURING SURGERY. THE HANDPIECE WAS REMOVED FROM THE EYE AND FLUSHED. SURGERY CONTINUED AND LATER ON A CORNEAL BURN WAS OBSERVED. THE WOUND WAS SUTURED AT THE END OF THE CASE. SURGERY WAS INCREASED BY 0-15 MINUTES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Eye Burn

  MAUDE report 16199633 ↗
• MalfunctionJun 3, 2022Particulates; Particulates

  THE USER FACILITY IN THE (B)(6) REPORTED THAT AN ORANGE PARTICLE WAS FOUND IN THE PATIENT''S EYE. THE PROCEDURE WAS EXTENDED BUT HOW LONG WAS UNKNOWN SINCE NOT TIMED. THERE WAS NO ADDITIONAL ANESTHESIA REQUIRED AND SURGERY WAS COMPLETED WITH NO PATIENT IMPACT OR CLINICAL CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14595629 ↗
• MalfunctionMay 7, 2022Particulates; Particulates

  THE USER FACILITY IN THE UNITED KINGDOM REPORTED A SMALL PARTICLE WAS FOUND IN THE PATIENT'S EYE. THE PARTICLE WAS REMOVED FROM THE PATIENT¿S EYE. THERE WAS NO PATIENT IMPACT OR CLINICAL CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14316793 ↗
• MalfunctionApr 21, 2022Particulates; Particulates

  A USER FACILITY IN THE UNITED KINGDOM REPORTS THAT A PIECE OF "METAL" CAME OUT OF THE HANDPIECE AND INTO THE EYE. THE SURGEON WAS ABLE TO RETRIEVE IT. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT/INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14166849 ↗
• MalfunctionApr 7, 2022Particulates; Particulates

  THE USER FACILITY IN THE (B)(6) REPORTED THAT DURING PHACO, SMALL WHITE PARTICULATE MATTER WAS EJECTED INTO THE ANTERIOR CHAMBER AND THEN LODGED INTO THE IRRIGATION PORT OF THE PHACO PROBE CAUSING THE ANTERIOR CHAMBER TO COLLAPSE AND STOPPING THE IRRIGATION FLOW. THE PARTICULATE WAS REMOVED FROM THE PATIENT'S EYE AND THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT IMPACT OR CLINICAL CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14045753 ↗
• MalfunctionMar 19, 2022Particulates; Particulates

  THE USER FACILITY IN THE (B)(6) REPORTED A WHITE PARTICLE WAS FOUND IN THE PATIENT''S EYE AFTER PHACOEMULSIFICATION. THE PROCEDURE WAS EXTENDED BY APPROXIMATELY 0-15 MINS. THERE WAS NO PATIENT IMPACT OR CLINICAL CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13826695 ↗
• InjuryFeb 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY IN FRANCE REPORTED THE SURGEON HAS SEEN THE PATIENT AGAIN AND HEALING IS PROGRESSING. THE SURGEON DECIDED TO LEAVE THE STITCHES IN PLACE AND WILL REMOVE AT A LATER TIME. THE PATIENT HAS A LOT OF ASTIGMATISM DUE TO THE STITCHES PULLING ON THE CORNEA.

  Patient problems: Eye Burn; Visual Impairment

  MAUDE report 13500503 ↗