Alcon Grieshaber 337.84Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 07612717071193), received between May 31, 2021 and Sep 24, 2026 — classified as 37 malfunctions.

The most frequently reported specific device problem is “Improper Flow or Infusion” (17 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Improper Flow or Infusion

  A physician reported that during test, an ophthalmic tip could not perform aspiration. Details of procedure was not reported. Additional information has been requested but is not available at the time of this report.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50881103 ↗
• MalfunctionSep 22, 2026Improper Flow or Infusion

  A physician reported that, during a vitrectomy procedure, the ophthalmic backflush tubing was blocked and unable to provide normal suction. The procedure was completed on the same day after replacing the backflush. Patient impact has not been provided. Additional information has been requested but is not available at the time of this report.

  Patient problems: Insufficient Information

  MAUDE report 50851514 ↗
• MalfunctionSep 15, 2026Improper Flow or Infusion

  The physician reported that during vitrectomy surgery, an ophthalmic device tube was blocked and cannot aspirate normally. The surgery was completed on the same day with alternative product. There was no further patient impact was reported, Additional information has been requested, but none received to date.

  Patient problems: Insufficient Information

  MAUDE report 50774187 ↗
• MalfunctionSep 12, 2026Improper Flow or Infusion

  Patient problems: Insufficient Information

  MAUDE report 50745345 ↗
• MalfunctionAug 14, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50255024 ↗
• MalfunctionAug 14, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50255022 ↗
• MalfunctionMay 11, 2026Break; Improper Flow or Infusion

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING VITREORETINAL SURGERY, THE OPHTHALMIC BACKFLUSH WAS UNABLE TO PERFORM ACTIVE SUCTION ON TWO OCCASIONS DUE TO LEAKAGE AT THE ASPIRATION CONNECTOR. THE SURGERY WAS COMPLETED ON THE SAME DAY, AND NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25134128 ↗
• MalfunctionApr 29, 2026Obstruction of Flow; Improper Flow or Infusion

  A NURSE REPORTED THAT, DURING VITRECTOMY SURGERY AN OPHTHALMIC BACKFLUSH SOFT TIP HEAD WAS BLOCKED AND DID NOT PROVIDE ASPIRATION. THE SURGERY WAS COMPLETED ON THE SAME DAY USING ANOTHER TIP WITHOUT ANY PATIENT HEALTH IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25025472 ↗
• MalfunctionApr 22, 2026Obstruction of Flow; Improper Flow or Infusion

  A HEALTH CARE PROFESSIONAL REPORTED THAT OPHTHALMIC TIP EXHIBITED NO SUCTION AND SUSPECTING SOMETHING BLOCKED INSIDE TIP. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24952818 ↗
• MalfunctionApr 15, 2026Improper Flow or Infusion

  A NURSE REPORTED THAT, DURING VITRECTOMY SURGERY AN OPHTHALMIC BACKFLUSH COULD NOT FUNCTION PROPERLY. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING WITH ANOTHER PRODUCT WITHOUT ANY PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24885241 ↗
• MalfunctionApr 5, 2026Break

  A NURSE REPORTED THAT THE SOFT TIP OF BACKFLUSH TUBING MALFUNCTIONED INTRAOPERATIVELY, DISLODGED AND FELL INTO PATIENT'S EYE GLOBE. THE SOFT TIP WAS ABLE TO BE RETRIEVED FROM PATIENT'S EYE, BY OPERATIVE SURGEON WITHOUT ANY ADVERSE PATIENT OUTCOMES. THE DETAILS OF THE SURGERY WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24786672 ↗
• MalfunctionMar 20, 2026Detachment of Device or Device Component; Activation Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A VITRECTOMY SURGERY, FOUR SILICONE TIPS ON THE OPHTHALMIC BACKFLUSH DEVICES FROM THE SAME BATCH WERE SHORT, AND ONE WAS DETACHED FROM THE CANNULA. PATIENT IMPACT HAS NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 24647513 ↗
• MalfunctionMar 13, 2026Improper Flow or Infusion

  A PHYSICIAN REPORTED THAT DURING THE PROCEDURE, THE BACKFLUSH NEEDLE WAS NO LONGER ASPIRATED. THERE WAS NO PATIENT CONTACT WITH THE DEVICE. PROCEDURE WAS COMPLETED ON THE SAME DAY WITHOUT ANY PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24588583 ↗
• MalfunctionFeb 20, 2026Obstruction of Flow; Improper Flow or Infusion

  A NURSE REPORTED THAT DURING VITRECTOMY SURGERY AN OPHTHALMIC DEVICE WITH TIP BLOCKAGE AND NO SUCTION. THE PRODUCT WAS CHANGED TO COMPLETE SURGERY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24399112 ↗
• MalfunctionNov 17, 2025Improper Flow or Infusion; Improper Flow or Infusion

  A NURSE REPORTED THAT AN OPTHALMIC ASPIRATION HANDLE WOULD NOT EXHIBIT THE ASPIRATION FUNCTION DURING THE SURGERY. THE SURGERY WAS COMPLETED BY CHANGING ANOTHER PRODUCT WITHOUT ANY PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23567743 ↗
• MalfunctionNov 10, 2025Improper Flow or Infusion; Improper Flow or Infusion

  A CUSTOMER REPORTED THAT DURING SURGERY, AN OPHTHALMIC BACKFLUSH WAS UNABLE TO ASPIRATE. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING THE BACKFLUSH, WITH NO HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT HAS NOT BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23508303 ↗
• MalfunctionNov 10, 2025Improper Flow or Infusion; Improper Flow or Infusion

  A CUSTOMER REPORTED THAT DURING SURGERY, AN OPHTHALMIC BACKFLUSH WAS UNABLE TO ASPIRATE. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING THE BACKFLUSH, WITH NO HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT HAS NOT BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23508302 ↗
• MalfunctionSep 17, 2025Suction Problem; Suction Problem

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC BACKFLUSH HANDPIECE DID NOT ASPIRATE AT ALL DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED NONE RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23074603 ↗
• MalfunctionSep 12, 2025Break; Break

  A PHYSICIAN REPORTED THAT TUBE WAS DISCONNECTED WHEN CONNECTED DURING SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23037086 ↗
• MalfunctionAug 22, 2025Suction Failure; Suction Failure

  A NURSE REPORTED THAT, BEFORE A VITRECTOMY SURGERY, THE SUCTION FUNCTION OF AN OPHTHALMIC BACKFLUSH SOFT TIP WAS NOT WORKING. THE PROCEDURE WAS COMPLETED ON THE SAME DAY BY REPLACING THE TIP WITH A NEW ONE, WITHOUT CAUSING ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED BUT HAS NOT BEEN RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874459 ↗
• MalfunctionAug 6, 2025Break; Break

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, AN OPHTHALMIC TIP BECAME STUCK IN THE TROCAR AND SUBSEQUENTLY BROKE INSIDE THE LUMEN MULTIPLE TIMES. THE PROCEDURE REQUIRED EXTENDED SURGICAL TIME AND ADDITIONAL MANEUVERS. THE SURGERY WAS COMPLETED BY REPLACING THE TIP WITH A NEW ONE. NO PATIENT IMPACT HAS BEEN REPORTED. THIS COMPLAINT PERTAINS TO ONE OF TWO REPORTS RECEIVED FROM THE SAME FACILITY.

  Patient problems: Insufficient Information

  MAUDE report 22726005 ↗
• MalfunctionJul 16, 2025Suction Failure; Suction Failure

  A NURSE REPORTED THAT THE OPHTHALMIC BACKFLUSH EXHIBITED SUCTION FAILURE DURING SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE BACKFLUSH, AND THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22517922 ↗
• MalfunctionMay 9, 2025Break; Improper Flow or Infusion; Break; Improper Flow or Infusion

  A NURSE REPORTED THAT AN OPHTHALMIC BACKFLUSH EXHIBITED WITH AIR LEAKAGE MAKING IT IMPOSSIBLE TO PERFORM ASPIRATION DURING VITRECTOMY SURGERY. SURGERY WAS COMPLETED AFTER REPLACING A PRODUCT WITH A NEW ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21993450 ↗
• MalfunctionMay 6, 2025Suction Failure; Suction Failure

  A NURSE REPORTED THAT DURING SURGERY THE SUCTION FROM AN OPHTHALMIC BACKFLUSH SOFT TIP WAS NOT WORKING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW TIP WITHOUT ANY HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21966635 ↗
• MalfunctionApr 22, 2025Improper Flow or Infusion; Improper Flow or Infusion

  A GOVERNMENT AGENCY REPORTED THAT AN OPHTHALMIC HANDPIECE TUBE WAS BLOCKED DURING CATARACT SURGERY. SURGERY WAS COMPLETED AFTER REPLACING PRODUCT WITH A NEW ONE. PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION COULD NO BE OBTAINED AS THE CUSTOMER WAS UNWILLING TO FOLLOW-UP.

  Patient problems: Insufficient Information

  MAUDE report 21882647 ↗