Alcon 8065441520Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380654415208), received between Mar 7, 2024 and Mar 8, 2024 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 8, 2024Complete Blockage; Complete Blockage

  A HEALTH PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY, FOUR OUT OF SIX OPHTHALMIC CANNULAS WAS FAULTY. THEY WERE ADDED ONTO A 2ML SYRINGE FILLED WITH BALANCED SALT SOLUTION AND IT WORKED AS NEEDED. WHEN RETURNING TO THE SYRINGE AND CANNULA AT A LATER STAGE OF THE CATARACT SURGERY, THE CANNULA WAS BLOCKED AND USED A DIFFERENT CANNULA. PATIENT IMPACT WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.

  Patient problems: Insufficient Information

  MAUDE report 18863922 ↗
• MalfunctionMar 7, 2024Partial Blockage; Partial Blockage

  A HEALTH PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY OPHTHALMIC CANNULAS WAS FOUND BLOCKED. THEY WERE ADDED ONTO A 2ML SYRINGE FILLED WITH BALANCED SALT SOLUTION AND IT WORKED AS NEEDED. WHEN RETURNING TO THE SYRINGE AND CANNULA AT A LATER STAGE OF SURGERY, THE CANNULA WAS BLOCKED. THREE CANNULA WAS UNBLOCKED BY APPLYING FORCE. SURGERY WAS COMPLETED WITH NO REPORT OF PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 18854340 ↗