Alcon 8065752182Recalls & reported problems

Summary

The FDA's MAUDE database contains 196 adverse event reports that list this exact device (DI 00380657521821), received between Mar 25, 2021 and Sep 24, 2026 — classified as 9 injuries, 187 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (68 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

Recent adverse event reports

The 25 most recent of 196 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Suction Problem

  A health care professional reported that the Cassette failed to perform cortex removal or viscoelastic aspiration during cataract surgery without intra ocular lens surgery. The surgery was completed on the same day but it was unknown how the surgery was completed. There was no information about patient impact.

  Patient problems: Insufficient Information

  MAUDE report 50877444 ↗
• MalfunctionFeb 16, 2026Obstruction of Flow

  A PHYSICIAN REPORTED THAT THE ABNORMAL SOUND WAS GENERATED DURING THE SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACED WITH SAME PRODUCT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24342199 ↗
• MalfunctionJan 30, 2026Suction Problem

  A PHYSICIAN REPORTED THAT THERE WAS NO SUCTION IN THE FLUID MANAGEMENT SYSTEM DURING ULTRASOUND MODE OF CATARACT SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE PROCEDURE WAS COMPLETED ON THE SAME DAY BY REPLACING WITH SIMILAR PRODUCT. THERE WAS PATIENT CONTACT BUT NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24220681 ↗
• MalfunctionJan 30, 2026Obstruction of Flow

  A HEALTHCARE PROFESSIONAL REPORTED THAT THERE WAS AN ABNORMAL SOUND DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION. THE SURGERY WAS COMPLETED ON THE SAME DAY WITHOUT PRODUCT REPLACEMENT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24219184 ↗
• MalfunctionJan 21, 2026Incomplete or Inadequate Connection

  A PHYSICIAN REPORTED THAT ADVISORY CODES WERE DISPLAYED DURING THE ULTRASOUND MODE OF THE SURGERY. THE PROCEDURAL TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24129476 ↗
• MalfunctionJan 21, 2026Suction Problem

  A PHYSICIAN REPORTED THAT ULTRASOUND ERROR OCCURRED OF CASSETTE DURING THE SURGERY. THE SURGERY TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED ON SAME DAY BY REPLACING THE PRODUCT. THE PRODUCT WAS CONTACTED WITH PATIENT BUT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24128018 ↗
• MalfunctionDec 25, 2025Suction Failure; Suction Failure

  A PHYSICIAN REPORTED THAT THE ASPIRATION FAILURE OCCURRED WHILE ON ULTRASOUND DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23894539 ↗
• MalfunctionDec 24, 2025Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED THAT THERE WAS ABNORMAL SOUND DURING ULTRASOUND MODE OF SURGERY (UNKNOWN PROCEDURE TYPE) LEADING TO OBSTRUCTION OF THE FLOW. THERE WAS PATIENT CONTACT WITH THE SUSPECT PRODUCT, BUT THE SURGERY WAS COMPLETED BY REPLACING THE PRODUCT AND THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23887774 ↗
• MalfunctionDec 23, 2025Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED THAT WHILE USING ULTRASOUND MODE, ABNORMAL NOISES WAS HEARD FROM THE PART OF THE CASSETTE PACK DURING THE CATARACT WITH INTRAOCULAR LENS IMPLANT SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY BUT REPLACEMENT DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23881859 ↗
• MalfunctionDec 23, 2025Suction Problem; Suction Problem

  A NURSE REPORTED THAT WHEN THE SURGEON ATTEMPTED TO USE THE HANDPIECE, SUFFICIENT VACUUM WAS NOT CREATED DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION. THE PROCEDURE WAS COMPLETED BY REPLACING THE CASSETTE WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23875410 ↗
• MalfunctionDec 22, 2025Suction Problem; Suction Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE ASPIRATION WAS WEAK DURING THE USE OF ULTRASOUND (US) FOR CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT. THE PROCEDURE WAS COMPLETED SAME SAY AFTER REPLACEMENT OF PRODUCT WITH NEW ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23861944 ↗
• MalfunctionDec 19, 2025Suction Problem; Suction Problem

  A NURSE REPORTED THAT AT THE MOMENT OF STARTING TO USE THE HANDPIECE, THERE WAS NOT ENOUGH VACUUM POWER IN PHACO PHASE DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION. THE HOSES (INCLUDING THE BLUE ASPIRATION HOSE), HANDPIECE, AND TIP WERE CHECKED, BUT THE VACUUM PARAMETER VALUES DID NOT INCREASE. THE SURGERY WAS COMPLETED WITH THIS CASSETTE. THE CASSETTE AND CONSOLE WERE CHANGED FOR THE NEXT PATIENT. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23851191 ↗
• MalfunctionDec 19, 2025Suction Problem; Suction Problem

  A CUSTOMER REPORTED THAT WHILE A CATARACT EXTRACTION SURGERY BY PHACOEMULSIFICATION WAS INITIATED BY PHYSICIAN, THERE WAS A LACK IN VACUUM STRENGTH WHEN USING THE HANDPIECE, DURING THE CORTICAL PHASE (DESPITE OF SCREEN INDICATING THAT THE VACUUM WAS INCREASING) AND AS WELL IN THE VISCOELASTIC ASPIRATION PHASE. FOR THE NEXT SURGERY, THE EQUIPMENT WAS RESTARTED AND THE CASSETTE WAS REPLACED AND THE PROBLEM WAS RESOLVED. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO IMPACT TO THE PATIENT. THIS REPORT PERTAINS TO CASSETTE INVOLVED IN REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23847281 ↗
• MalfunctionDec 12, 2025Obstruction of Flow; Obstruction of Flow

  A NURSE REPORTED THAT THE CASSETTE BEGINS TO GENERATE A SOUND THAT DOES NOT AFFECT FLUIDICS DURING SURGERY. THE PROCEDURE TYPE AND SURGERY COMPLETION DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23786468 ↗
• MalfunctionDec 10, 2025Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED THAT THE ULTRASOUND FRACTURING STOPPED MOVING OF PHACOEMULSIFICATION (PHACO) TIP DURING THE SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY BY REPLACING THE PHACO TIP. THE PRODUCT WAS CONTACTED WITH PATIENT BUT THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23768822 ↗
• MalfunctionNov 28, 2025Suction Failure; Suction Failure

  A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY (WITH INTRA OCULAR LENS IMPLANTATION), NO ASPIRATION WAS PERFORMED. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH A REPLACEMENT. THERE WAS PATIENT CONTACT BUT NO INFORMATION ABOUT ANY PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23669719 ↗
• MalfunctionNov 27, 2025Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED THAT ASPIRATION PRODUCES AN ABNORMAL SOUND NEAR THE PACK DURING CATARACT SURGERY (WITH INTRAOCULAR LENSES IMPLANT). THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23665056 ↗
• MalfunctionNov 27, 2025Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED THAT ABNORMAL NOISE OCCURRED DURING THE SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23663722 ↗
• MalfunctionNov 25, 2025Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED THAT ABNORMAL NOISE OCCURRED DURING THE SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646224 ↗
• MalfunctionNov 19, 2025Suction Problem; Appropriate Device Problem Term/Code Not Available; Suction Problem; Appropriate Device Problem Term/Code Not Available

  A PHYSICIAN REPORTED THAT THE ASPIRATION BECAME POOR AND SYSTEM MESSAGE VACUUM CHECK FAILED DURING CATARACT WITH INTRAOCULAR LENS IMPLANTATION SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23591993 ↗
• MalfunctionNov 18, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  A PHYSICIAN REPORTED THAT SLEEVE WAS FOUND TORN DURING CATARACT SURGERY (WITH INTRAOCULAR LENS IMPLANT). THE SURGERY WAS CONTINUED AND COMPLETED AFTER REPLACING THE SLEEVE WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23589938 ↗
• MalfunctionNov 14, 2025Suction Problem; Suction Problem

  A PHYSICIAN REPORTED THAT SUCTION STOPPED DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 23552188 ↗
• MalfunctionNov 11, 2025Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED THAT AN ABNORMAL NOISE OCCURRED FROM THE CASSETTE DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION. THE PROCEDURE WAS COMPLETED BY REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23520466 ↗
• MalfunctionNov 10, 2025Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED THAT ABNORMAL NOISE OCCURRED FROM THE CASSETTE DURING THE CATARACT WITH INTRAOCULAR LENS IMPLANT SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23510106 ↗
• MalfunctionOct 20, 2025Obstruction of Flow; Appropriate Device Problem Term/Code Not Available; Obstruction of Flow; Appropriate Device Problem Term/Code Not Available

  A PHYSICIAN REPORTED THAT POWDER-LIKE FOREIGN MATERIAL WAS OBSERVED IN THE EYE DURING THE INITIAL IRRIGATION FOLLOWING A TEST, AND AN ABNORMAL NOISE WAS NOTED DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION WAS RECEIVED REGARDING PATIENT BODY SITE (OS OCULUS SINISTER).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23334136 ↗