Alcon Grieshaber 337.86Recalls & reported problems
Alcon Laboratories, Inc. · Advanced DSP Backflush Soft Tip, 23G · Class 1
All models of Alcon Grieshaber (17)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07612717071216), received between Feb 26, 2024 and Apr 23, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Break” (2 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.
Reports received per month
Most reported problems
Device problems
- Break2
- Improper Flow or Infusion2
- Suction Failure2
- Complete Blockage1
- Obstruction of Flow1
- Retraction Problem1
Patient problems
- Insufficient Information4
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2026Break
THE NURSE REPORTED THAT DURING VITRECTOMY SURGERY, AN OPHTHALMIC BACKFLUSH BRUSH HEAD HOSE FALLS OFF. THE SURGERY WAS COMPLETED ON THE SAME DAY. DETAILS OF PATIENT IMPACT WAS NOT REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24963954 ↗MalfunctionMar 19, 2026Obstruction of Flow; Improper Flow or Infusion
THE CUSTOMER REPORTED THAT DURING A VITREOUS SILICONE OIL REMOVAL SURGERY, THE OPHTHALMIC BACKFLUSH EXPERIENCED BLOCKAGE AND POOR SUCTION, MAKING IT IMPOSSIBLE TO PERFORM THE OPERATION. THE SURGERY WAS COMPLETED THE SAME DAY AFTER REPLACING THE PRODUCT, AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24637447 ↗MalfunctionSep 12, 2025Break; Break
A CUSTOMER REPORTED THAT DURING SURGERY, AN OPHTHALMIC HANDLE HAD AIR LEAKING AT THE CONNECTION. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THE PATIENT IMPACT HAS NOT BEEN REPORTED.
Patient problems: Insufficient Information
MAUDE report 23035940 ↗MalfunctionApr 24, 2025Improper Flow or Infusion; Improper Flow or Infusion
A NURSE REPORTED THAT BEFORE SURGERY, THE OPHTHALMIC BACKFLUSH HAD NO ASPIRATION FORCE. THE SURGERY WAS COMPLETED USING A NEW DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21898221 ↗MalfunctionMar 11, 2025Complete Blockage; Suction Failure; Complete Blockage; Suction Failure
A NURSE REPORTED THAT DURING VITRECTOMY SURGERY, THE OPHTHALMIC BACKFLUSH OBSTRUCTED AND THE LIQUID COULD NOT PASS THROUGH. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH AN ALTERNATIVE BACKFLUSH AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21571112 ↗MalfunctionApr 8, 2024Suction Failure; Suction Failure
ADDITIONAL INFORMATION RECEIVED, INDICATED THAT EVENT OCCURRED BEFORE SURGERY.
Patient problems: Insufficient Information
MAUDE report 19059753 ↗MalfunctionFeb 26, 2024Retraction Problem; Retraction Problem
A CUSTOMER REPORTED THAT AN OPHTHALMIC TIP DURING USE CANNOT BE RETRACTED. THE PROCEDURE DETAILS AND PATIENT IMPACT WAS NOT REPORTED.
Patient problems: Insufficient Information
MAUDE report 18776302 ↗
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- Vortex Surgical Inc VS0200.25Vortex Surgical, Inc. · Cannula, Ophthalmic1 recall0 reports
- Disposable Replacement backflush brush Needles. (23 gauge / 0.6mm) 1281.B1D06D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Cannula, Ophthalmic1 recall0 reports
- Vortex Surgical Inc VS0200.27Vortex Surgical, Inc. · Cannula, Ophthalmic1 recall0 reports
- Vortex Surgical Inc VS0220.25Vortex Surgical, Inc. · Cannula, Ophthalmic1 recall0 reports
- Visitec® 585278Beaver-Visitec International, Inc. · Cannula, Ophthalmic1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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