Alcon 8065480120Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380654801209), received between Dec 1, 2022 and Sep 21, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Complete 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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2024Obstruction of Flow; Obstruction of Flow

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC PLUNGER WAS PRESSED BUT COULD NOT BE PUSHED AND NO CHEMICAL SOLUTION CAME OUT BEFORE SURGERY. DETAILS OF PROCEDURE AND PATIENT HARM WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20275140 ↗
• MalfunctionOct 3, 2023Fitting Problem; Fitting Problem

  A CUSTOMER REPORTED THAT DURING THE SURGERY AN OPHTHALMIC OPERATING SOFT TIP CANNULA WAS DIFFICULTY ENTERING THROUGH THE VALVED TROCAR. THERE WAS NO DETAILS OF PROCEDURE AND PATIENT DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17860900 ↗
• MalfunctionJan 27, 2023Complete Blockage; Complete Blockage

  A CUSTOMER REPORTED THAT DURING CATARACT SURGERY CANNULA WAS BLOCKED THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITHOUT ANY PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16252565 ↗
• InjuryDec 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LITERATURE ARTICLE REVEALED THAT WHILE TREATING A PATIENT BEFORE ENTERING THE ANTERIOR CHAMBER, OPHTHALMIC VISCOSURGICAL DEVICE WAS ACCIDENTALLY INJECTED INTO THE CORNEAL STROMA, LEAVING A 4MM OPACITY SUPERONASAL WITHIN 4 MM OF THE CENTRAL CORNEA, ON THE FIRST POSTOPERATIVE DAY VISION IMPROVED AND THERE WAS MILD SUPERIOR CORNEAL EDEMA, BY WEEKS AFTER SURGERY THE VISUAL ACUITY IMPROVED. THE CANNULA USED TO INJECT VISCOELASTIC MAY HAD CONTRIBUTED TO THE REPORTED EVENT. NO FURTHER INFORMATION EXPECTED DUE TO UNLIKELIHOOD.

  Patient problems: Corneal Clouding/Hazing; Corneal Edema

  MAUDE report 15898932 ↗