Alcon 8065752202Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380657522026), received between Jun 9, 2021 and Dec 11, 2023 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Inability to Irrigate” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 28, 2023Open, Classified

   Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.

   Z-2407-2023 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2023Complete Blockage; Complete Blockage

  A PHYSICIAN REPORTED THAT THE CASSETTE TUBE WAS CLOGGED DURING IRRIGATION OR ASPIRATION SURGERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER PACK. THE PATIENT HARM DETAILS WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18303067 ↗
• MalfunctionSep 11, 2023Inability to Irrigate; Inability to Irrigate

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT THERE WAS NO IRRIGATION OF FLUIDICS MANAGEMENT SYSTEM (FMS) WHEN IT WAS IN IRRIGATION ASPIRATION MODE DURING CATARACT SURGERY. THERE WERE NO SYSTEM MESSAGES OR ERROR CODES. THEY HAD TO OPEN NEW PACKS TO COMPLETE THE PROCEDURES. THIS OCCURRED PRIOR TO PATIENT CONTACT BUT DURING SURGERY AFTER CORTEX. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17719733 ↗
• MalfunctionSep 11, 2023Inability to Irrigate; Inability to Irrigate

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT THERE WAS NO IRRIGATION OF FLUIDICS MANAGEMENT SYSTEM (FMS) WHEN IT WAS IN IRRIGATION ASPIRATION MODE DURING CATARACT SURGERY. THERE WERE NO SYSTEM MESSAGES OR ERROR CODES. THEY HAD TO OPEN NEW PACKS TO COMPLETE THE PROCEDURES. THIS OCCURRED PRIOR TO PATIENT CONTACT BUT DURING SURGERY AFTER CORTEX. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17719638 ↗
• MalfunctionSep 11, 2023Inability to Irrigate; Inability to Irrigate

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT THERE WAS NO IRRIGATION OF FLUIDICS MANAGEMENT SYSTEM (FMS) WHEN IT WAS IN IRRIGATION ASPIRATION MODE DURING CATARACT SURGERY. THERE WERE NO SYSTEM MESSAGES OR ERROR CODES. THEY HAD TO OPEN NEW PACKS TO COMPLETE THE PROCEDURES. THIS OCCURRED PRIOR TO PATIENT CONTACT BUT DURING SURGERY AFTER CORTEX. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17719634 ↗
• MalfunctionApr 24, 2023Air/Gas in Device; Air/Gas in Device

  A PHARMACIST REPORTED DURING NUCLEUS REMOVAL/ASPIRATION, SURGEON NOTED BUBBLES CAME FROM HANDPIECE, THESE BUBBLES IMPEDED THE SURGEON'S VISION. THERE WAS NO IMPACT ON PATIENT. BUBBLES WERE ASPIRATED. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NONE HAS BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16793963 ↗
• MalfunctionMar 3, 2023Air/Gas in Device; Air/Gas in Device

  A PHARMACIST REPORTED THAT BUBBLES WERE NOTED DURING SCULPTURE AND QUADRANT STEPS WHICH LED TO OBSTRUCTION IN THE SURGEON'S VIEW WHILE PERFORMING THE CATARACT PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16477791 ↗
• MalfunctionJul 19, 2022Break; Break

  A PHYSICIAN REPORTED BROKEN PHACOEMULSIFICATION TIP BROKE OUT OF PATIENT'S EYE DURING SCULPTING PHASE OF THE CATARACT PROCEDURE; HOWEVER, THERE WAS NO PATIENT CONTACT WHEN THIS WAS OBSERVED. THE BROKEN TIP WAS REPLACED BY A MINI TIP FOR COMPLETING THE PROCEDURE. THERE WAS NO PATIENT HARM. THERE WERE TWO PRODUCTS REPORTED FROM THE SITE AS POTENTIALLY INVOLVED THE REPORTER COULD NOT PROVIDE CLARIFICATION REGARDING WHICH PRODUCT IS ASSOCIATED WITH THIS COMPLAINT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15051057 ↗
• MalfunctionJul 19, 2022Break; Break

  A PHYSICIAN REPORTED BROKEN PHACOEMULSIFICATION TIP BROKE OUT OF PATIENT'S EYE DURING SCULPTING PHASE OF THE CATARACT PROCEDURE; HOWEVER, THERE WAS NO PATIENT CONTACT WHEN THIS WAS OBSERVED. THE BROKEN TIP WAS REPLACED BY A MINI TIP FOR COMPLETING THE PROCEDURE. THERE WAS NO PATIENT HARM. THERE WERE TWO PRODUCTS REPORTED FROM THE SITE AS POTENTIALLY INVOLVED THE REPORTER COULD NOT PROVIDE CLARIFICATION REGARDING WHICH PRODUCT IS ASSOCIATED WITH THIS COMPLAINT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15051053 ↗
• InjuryJan 3, 2022No Flow; No Flow

  A PHYSICIAN REPORTED NO IRRIGATION FLOW THROUGH THE SLEEVE WOUND BURN OCCURRED SOMEWHERE AROUND SCULPTING AND MOVING TO QUADRANT REMOVAL IN THE LEFT EYE DURING A CATARACT SURGERY. THE WOUND WAS SUTURED AND CLOSED.

  Patient problems: Burn(s)

  MAUDE report 13141582 ↗
• MalfunctionJun 9, 2021Suction Failure; Suction Failure

  A CUSTOMER REPORTED THAT THE CASSETTE DID NOT ASPIRATE DURING SURGERY. THE PRODUCT WAS REPLACED AND THE SURGERY WAS COMPLETED. THERE IS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11969146 ↗