Alcon 8065751014Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00380657510146), received between Sep 11, 2020 and Aug 8, 2024 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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. Aug 5, 2025Open, Classified

   Due to incomplete seals in the pouch which provide the sterile barrier.

   Z-0305-2026 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryAug 8, 2024Radiofrequency Interference (RFI); Radiofrequency Interference (RFI)

  A CUSTOMER REPORTED THAT DURING SURGERY, THE AUTO GAS FILED DEVICE WAS EJECTED FROM OPHTHALMIC SYSTEM WITH SUFFICIENT FORCE TO IMPACT THE SURGICAL TECHNICIAN STANDING INFRONT OF THE SYSTEM. THE TECHNICIAN HAD MILD TO MODERATE SORE FOR FEW DAYS DUE TO THE IMPACT OF GAS EXPULSE FROM THE SYSTEM. THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT IMPACT AND PROCEDURE DETAILS WERE NOT REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19936108 ↗
• MalfunctionApr 13, 2024Material Separation; Material Separation

  A PHYSICIAN REPORTED THAT THE TUBE CAME OFF DUE TO PRESSURE OF GAS DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED BY USING ANOTHER PRODUCT FROM DIFFERENT LOT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19102581 ↗
• MalfunctionMar 8, 2024Disconnection; Fitting Problem; Disconnection; Fitting Problem

  BASED ON THE INFORMATION RECEIVED FOLLOWING SUBMISSION OF THE INITIAL REPORT, THIS EVENT ¿TUBE FOUND DISCONNECTED, SYRINGE PART WAS TOUCHING A STOPPER¿ DURING SURGERY DOES NOT MEET CRITERIA FOR REPORTING AS A REPORTABLE MALFUNCTION SINCE IT WAS ONLY ISSUE WITH AUTO GAS FILLING NOT WITH THE CASSETTE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18866300 ↗
• MalfunctionNov 15, 2023Suction Problem; Gas/Air Leak; Suction Problem; Gas/Air Leak

  A PHYSICIAN REPORTED THAT ASPIRATION FAILURE AND SUCTION ISSUE OCCURRED DURING SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PROCEDURE TYPE WAS UNKNOWN. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18137786 ↗
• MalfunctionOct 16, 2023No Flow; No Flow

  A CUSTOMER REPORTED THAT THE FLUID AIR EXCHANGE WOULD FILL WITH GAS BUT WOULD NOT EXCHANGE DURING SURGERY. THE PROCEDURE AND PATIENT HARM DETAILS WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17940053 ↗
• MalfunctionOct 7, 2022Disconnection; Device Markings/Labelling Problem; Disconnection; Device Markings/Labelling Problem

  A PHYSICIAN REPORTED CONNECTING PART CAME OFF SEVERAL TIMES WHEN SUCKING GAS FROM THE CONSTELLATION DURING A SURGERY. A STICKER WITH SF6/C3F8 STATED WAS NOT INCLUDED. THE SURGERY TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED AFTER THE PRODUCT WAS REPLACED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15561832 ↗
• MalfunctionMay 31, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  A PHYSICIAN REPORTED TUBE CAME OFF ON ITS OWN AT THE TIME OF THE PURGE DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED AFTER THE PRODUCT WAS REPLACED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14545948 ↗
• MalfunctionFeb 24, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A CUSTOMER REPORTED THE CASSETTE LEAKED. THE PROCEDURE AND PATIENT IMPACT DETAILS WERE NOT PROVIDED. THERE WAS NO REPORT OF PATIENT HARM. ADDITIONAL INFORMATION RECEIVED FROM COMPANY REPRESENTATIVE WHO INDICATED THE MALFUNCTION OCCURRED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED AFTER THE PRODUCT WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13591560 ↗
• MalfunctionFeb 24, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A CUSTOMER REPORTED THE CASSETTE LEAKED. THE PROCEDURE AND PATIENT IMPACT DETAILS WERE NOT PROVIDED. THERE WAS NO REPORT OF PATIENT HARM. ADDITIONAL INFORMATION RECEIVED FROM COMPANY REPRESENTATIVE WHO INDICATED THE MALFUNCTION OCCURRED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED AFTER THE PRODUCT WAS REPLACED..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13591530 ↗
• MalfunctionFeb 24, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A CUSTOMER REPORTED THE CASSETTES LEAKED. THE PROCEDURE AND PATIENT IMPACT DETAILS WERE NOT PROVIDED. THERE WAS NO REPORT OF PATIENT HARM. ADDITIONAL INFORMATION RECEIVED FROM COMPANY REPRESENTATIVE WHO INDICATED THE MALFUNCTION OCCURRED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED AFTER THE PRODUCT WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13591140 ↗
• MalfunctionSep 11, 2020Inability to Auto-Fill

  THE SYRINGE (AUTO GAS FILL PAK) WAS HOOKED UP TO THE CONSTELLATION SYSTEM AND "AUTO FILL" BUTTON WAS PRESSED. THE SYRINGE DID NOT FILL AS ANTICIPATED. A NEW PAK WAS OPENED AND USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10520718 ↗