Alcon 8065420020Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380654200200), received between Oct 25, 2023 and Jul 9, 2025 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION INDICATED THAT THE MOST RECENT CHART NOTE WAS FROM A NINE-DAY POSTOPERATIVE VISIT FOLLOWING INTRAOCULAR LENS (IOL) REPOSITIONING. THE BLURRINESS HAD IMPROVED, ALTHOUGH THE VISION REMAINED SOMEWHAT BLURRY. HOWEVER, THE GENERAL POSTOPERATIVE APPEARANCE WAS GOOD, WITH NO SIGNS OF TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THE PATIENT WAS ADVISED TO RETURN FOR SERIAL REFRACTIONS AT FUTURE VISITS.

  Patient problems: Blurred Vision; Conjunctivitis; Corneal Edema; Eye Pain; Inflammation; Intraocular Pressure Increased; Red Eye(s); Toxic Anterior Segment Syndrome (TASS)

  MAUDE report 22460102 ↗
• MalfunctionOct 23, 2024Obstruction of Flow; Obstruction of Flow

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING SETUP FOR MULTIPLE CATARACT SURGERIES, THE OPHTHALMIC CANNULAS WERE OCCLUDED MULTIPLE TIMES. THE SURGERIES WERE COMPLETED ON THE SAME DAY AFTER REPLACING WITH OTHER CANNULAS. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20513180 ↗
• MalfunctionSep 26, 2024Obstruction of Flow; Obstruction of Flow

  A NURSE REPORTED THAT AN OPHTHALMIC CANNULA WAS BLOCKED. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 20307243 ↗
• MalfunctionAug 26, 2024Complete Blockage; Complete Blockage

  A CUSTOMER REPORTED THAT NO LIQUID COULD BE PUSHED OUT FROM THE SYRINGE TO THE CANNULA BEFORE SURGERY. PATIENT AND PROCEDURE DETAILS WERE NOT REPORTED. NO PATIENT HARM WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20065842 ↗
• MalfunctionMay 22, 2024Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  A COMPANY REPRESENTATIVE REPORTED ON BE HALF OF A NURSE, THE OPHTHALMIC CANNULA CAME OFF THE SYRINGE DURING A GLAUCOMA SURGERY IN LEFT EYE. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT HARM REPORTED. THIS REPORT IS FOR THE THIRD OF THREE CASES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19372033 ↗
• MalfunctionMay 22, 2024Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  A COMPANY REPRESENTATIVE REPORTED ON BE HALF OF A NURSE, THE OPHTHALMIC CANNULA CAME OFF THE SYRINGE DURING A GLAUCOMA SURGERY IN LEFT EYE. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT HARM REPORTED. THIS REPORT IS FOR THE THIRD OF THREE CASES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19371978 ↗
• MalfunctionMay 22, 2024Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component

  A COMPANY REPRESENTATIVE REPORTED ON BE HALF OF A NURSE, THE OPHTHALMIC CANNULA CAME OFF THE SYRINGE DURING A GLAUCOMA SURGERY IN LEFT EYE. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT HARM REPORTED. THIS REPORT IS FOR THE THIRD OF THREE CASES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19370151 ↗
• MalfunctionApr 15, 2024Obstruction of Flow; Obstruction of Flow

  A CUSTOMER REPORTED THAT OPHTHALMIC CANNULA WAS WOULD NOT FLUSH DURING SETUP. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING WITH ANOTHER PRODUCT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19104741 ↗
• MalfunctionApr 2, 2024Obstruction of Flow; Obstruction of Flow

  A CUSTOMER REPORTED THAT BEFORE CATARACT SURGERY, AN OPHTHALMIC CANNULA NOT ABLE TO FLUSH. THE PROCEDURE WAS COMPLETED USING ANOTHER NEW DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19020735 ↗
• MalfunctionMar 26, 2024Complete Blockage; Complete Blockage

  A CUSTOMER REPORTED THAT AN OPHTHALMIC OPERATING CANNULA WAS USED DURING THE SURGERY. THE CANNULA WAS FOUND TO BE CLOGGED. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO REPORT OF PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18976807 ↗
• MalfunctionDec 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A CUSTOMER REPORTED THAT DURING A CATARACT SURGERIES PRIOR TO HYDRATING THE WOUND THE CANNULA WAS POPPING OFF AND LANDING ON THE STERILE FIELD. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18344746 ↗
• InjuryOct 25, 2023Fitting Problem; Fitting Problem

  ADDITIONAL INFORMATION RECEIVED THAT PATIENT ALSO EXPERIENCED THE EVENTS VITREOUS INVADED THE ANTERIOR CHAMBER, VITREOUS HEMORRHAGE OF THE RIGHT EYE, VISUAL ACUITY IS NOT YET CLEAR DUE TO CORNEAL EDEMA AND HEMORRHAGE, THE NEWLY PLACED INTRAOCULAR LENS WAS REMOVED AND THE CANNULA HUB OF THE SYRINGE ONLY TURNING ONE ROTATION ON THE LUER LOCK HUB. THE CURRENT OUTCOME OF THE PATIENT WAS UNKNOWN.

  Patient problems: Blurred Vision; Capsular Bag Tear; Corneal Edema; Prolapse; Vitreous Hemorrhage

  MAUDE report 18004580 ↗