Alcon Grieshaber 27+ 337.88Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 07612717071414), received between Apr 5, 2021 and Jun 26, 2026 — classified as 3 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Suction Failure” (5 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2026Improper Flow or Infusion

  A PHYSICIAN REPORTED THAT THE OPHTHALMIC BACKFLUSH DEVICE WAS UNABLE TO ASPIRATE DURING SURGERY. THE SPECIFIC PROCEDURE TYPE WAS NOT PROVIDED. NO PATIENT IMPACT WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25634299 ↗
• MalfunctionDec 22, 2025Improper Flow or Infusion; Improper Flow or Infusion

  A PHYSICIAN REPORTED THAT ASPIRATION FAILURE OCCURRED DURING SURGERY. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. PATIENT HARM WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23863649 ↗
• MalfunctionDec 8, 2025Improper Flow or Infusion; Improper Flow or Infusion

  THE PHYSICIAN REPORTED THAT DURING SURGERY OPHTHALMIC BACKFLUSH COULD NOT ASPIRATE. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM. THE PROCEDURE DETAILS HAVE BEEN REQUESTED, BUT NONE RECEIVED TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23741428 ↗
• MalfunctionOct 28, 2025Suction Problem; Suction Problem

  A PHYSICIAN REPORTED THAT DURING VITRECTOMY SURGERY OPHTHALMIC HANDPIECE WAS UNABLE TO ASPIRATE. PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE RECEIVED TILL DATE.

  Patient problems: Insufficient Information

  MAUDE report 23400790 ↗
• MalfunctionJul 23, 2025Suction Failure; Suction Failure

  A PHYSICIAN REPORTED THAT THE OPHTHALMIC PRODUCT DID NOT ASPIRATE DURING CATARACT AND VITRECTOMY SURGERY. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE INVOLVED EYE AND THE PATIENT IDENTIFIER ARE NOT AVAILABLE. THERE'S NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22574271 ↗
• MalfunctionMay 30, 2025Improper Flow or Infusion; Improper Flow or Infusion

  A PHYSICIAN REPORTED THAT BEFORE INSERTION ASPIRATION FAILURE OF A PROBE OCCURRED IN VITRECTOMY SURGERY. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE ON THE SAME DAY. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22115774 ↗
• InjuryJun 26, 2024Break; Device Handling Problem; Break; Device Handling Problem

  A CUSTOMER REPORTED THAT DURING VITRECTOMY SURGERY, AN OPHTHALMIC FORCEPS TIP FELL INTO THE PATIENT'S EYE AND COULD NOT BE RETRIEVED. A SECONDARY PROCEDURE WAS CONDUCTED TO RETRIEVE THE DEVICE FROM THE PATIENT'S EYE. IT WAS FURTHER REPORTED THAT THE DEVICE HAD ALREADY EXPIRED BEFORE THE EVENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 19617416 ↗
• MalfunctionApr 29, 2024Material Twisted/Bent; Material Twisted/Bent

  A CUSTOMER REPORTED THAT THE HEAD OF THE OPHTHALMIC HANDLE CROOKED DURING SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE DETAILS OF PATIENT IMPACT WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19201269 ↗
• MalfunctionJan 16, 2024Suction Problem; Suction Problem

  A PHYSICIAN REPORTED THAT DURING A CATARACT/VITRECTOMY COMBINATION SURGERY ASPIRATION FAILURE OCCURRED IN AN OPHTHALMIC DISPOSABLE BACKFLUSH. THE SURGERY WAS COMPLETED BY AN ALTERNATE PRODUCT. THERE WAS NO PATIENT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18516895 ↗
• MalfunctionOct 19, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC TIP DETACHED FROM THE CANNULA DURING THE VITREORETINAL PROCEDURE AND FELL INTO THE BACK OF THE PATIENT'S EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE RECEIVED TO DATE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17963858 ↗
• MalfunctionSep 6, 2023Fitting Problem; Fitting Problem

  A PHYSICAN REPORTED THAT DURING SURGERY AN OPHTHALMIC BACKFLUSH SHAFT PART WAS STUCK COULD NOT BE INSERTED INTO THE EYE. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE'S NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17688013 ↗
• MalfunctionAug 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A CUSTOMER REPORTED THAT OPHTHALMIC BACKFLUSH SOFT TIP WAS MISSING INSIDE THE PACKAGING. THE PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17555573 ↗
• MalfunctionJul 18, 2023Fluid/Blood Leak; Suction Failure; Fluid/Blood Leak; Suction Failure

  A PHYSICIAN REPORTED THAT DURING THE SURGERY AN OPHTHALMIC HANDPIECE ASPIRATION/IRRIGATION WAS NOT WORKING AS THE LEAKAGE OCCURRED AT THE CENTER PART OF THE HANDLE. PROCEDURE DETAILS WAS NOT PROVIDED. THERE IS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17341541 ↗
• MalfunctionJul 18, 2023Fluid/Blood Leak; Suction Failure; Fluid/Blood Leak; Suction Failure

  A PHYSICIAN REPORTED THAT DURING THE SURGERY AN OPHTHALMIC HANDPIECE ASPIRATION/IRRIGATION WAS NOT WORKING AS THE LEAKAGE OCCURRED AT THE CENTER PART OF THE HANDLE. PROCEDURE DETAILS WAS NOT PROVIDED. THERE IS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17341540 ↗
• MalfunctionJul 18, 2023Fluid/Blood Leak; Inability to Irrigate; Suction Failure; Fluid/Blood Leak; Inability to Irrigate; Suction Failure

  A PHYSICIAN REPORTED THAT DURING THE SURGERY AN OPHTHALMIC BACKFLUSH EXHIBITED IRRIGATION ISSUES AS THE LEAKAGE OCCURRED AT THE CENTER PART OF THE HANDLE AND IRRIGATION WAS ABSENT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17340774 ↗
• MalfunctionJul 18, 2023Fluid/Blood Leak; Inability to Irrigate; Suction Failure; Fluid/Blood Leak; Inability to Irrigate; Suction Failure

  A PHYSICIAN REPORTED THAT DURING THE SURGERY AN OPHTHALMIC BACKFLUSH EXHIBITED IRRIGATION ISSUES AS THE LEAKAGE OCCURRED AT THE CENTER PART OF THE HANDLE AND IRRIGATION WAS ABSENT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17340773 ↗
• MalfunctionJun 19, 2023Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT DURING THE SURGERY, OPHTHALMIC TIP COULD NOT BE INSERTED INTO TROCAR DURING INSERTION. IT WAS UNKNOWN WHETHER THE SURGERY WAS COMPLETED OR NOT. THE INVOLVED EYE AND THE PATIENT IDENTIFIER ARE NOT AVAILABLE. THERE WAS NO PATIENT HARM. THE PROCEDURE TYPE WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17150746 ↗
• MalfunctionFeb 8, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  A PHYSICIAN REPORTED THAT DURING A COMBINED CATARACT AND VITRECTOMY FOR RETINAL DETACHMENT PROCEDURE AN OPHTHALMIC BACKFLUSH TIP CAME LOOSE DURING THE FLUID/AIR EXCHANGE (FAX) MODE AND REMAINED IN THE EYE. THE SURGERY WAS COMPLETED AND PATIENT IMPACT WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16326023 ↗
• MalfunctionJan 23, 2023Connection Problem; Connection Problem

  A PHYSICIAN REPORTED DURING SURGERY TIP OF THE TROCAR CANNULA CAME OFF OUT OF THE EYE WHEN USING IT WITH THE PRODUCT BEFORE INSERTING. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM. PROCEDURE AND PATIENT IDENTIFIER DETAILS WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16222692 ↗
• MalfunctionJan 23, 2023Connection Problem; Connection Problem

  A PHYSICIAN REPORTED DURING SURGERY TIP OF THE TROCAR CANNULA CAME OFF OUT OF THE EYE WHEN USING IT WITH THE PRODUCT BEFORE INSERTING. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM. PROCEDURE AND PATIENT IDENTIFIER DETAILS WERE NOT REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16222691 ↗
• MalfunctionJan 20, 2023Particulates; Particulates

  A NURSE REPORTED THAT DURING A COMBINED CATARACT AND VITRECTOMY FOR RETINAL DETACHMENT PROCEDURE AN OPHTHALMIC BACKFLUSH TIP CAME LOOSE DURING THE FLUID/AIR EXCHANGE (FAX) MODE AND REMAINED IN THE EYE. THE SURGERY WAS COMPLETED AND PATIENT IMPACT WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16213433 ↗
• MalfunctionJan 12, 2023Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT DURING A VITRECTOMY SURGERY AN OPHTHALMIC BACKFLUSH COULD NOT BE TAKEN OUT WHEN PUSHING INTO TROCAR. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16148080 ↗
• MalfunctionDec 21, 2022Fitting Problem; Fitting Problem

  A CUSTOMER REPORTED THAT AN DURING A VITRECTOMY SURGERY OPHTHALMIC BACKFLUSH DID NOT ENTER THROUGH TROCAR. SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16025381 ↗
• InjuryJun 10, 2022Disconnection; Disconnection

  A PHYSICIAN REPORTED THAT THE TIP OF AN OPHTHALMIC BACKFLUSH DEVICE FELL OFF IN THE PATIENT'S EYE DURING A VITRECTOMY PROCEDURE. THE EYE IS FILLED WITH SILICONE OIL. THE PHYSICIAN INDICATED THAT THE TIP MIGHT COME OUT WHEN THE SILICONE OIL WOULD BE REMOVED FROM THE EYE. THE CURRENT PATIENT PROGNOSIS WAS GOOD.

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

  MAUDE report 14654915 ↗
• InjuryMay 18, 2022Break; Break

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC BACKFLUSH CAME OFF IN THE PATIENT'S EYE DURING RETINAL DETACHMENT SURGERY. THE PATIENT UNDERWENT TO A MEDICAL INTERVENTION TO REMOVE THE BROKEN TIP. ADDITIONAL INFORMATION HAS BEEN REQUESTED NONE RECEIVED TILL DATE.

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

  MAUDE report 14433139 ↗