Alcon 8065149529Recalls & reported problems
Alcon Laboratories, Inc. · Microsurgical Instrument 27G Soft Tip Cannula, DSP, 0.8mm · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Alcon 27G Soft Tip Cannula is a fine microsurgical instrument used in eye surgery, mainly during retinal procedures. The 33 adverse event reports mostly describe the soft silicone tip detaching or separating, sometimes falling into the eye and having to be removed with forceps, which in two reports prolonged surgery and required extra suturing. No deaths were reported and 2 injuries were. No recalls name this device. Reports have dropped sharply, from 13 in the previous 12 months to 2.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 32
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00380651495296), received between Oct 26, 2022 and Feb 27, 2026 — classified as 2 injuries, 30 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component17
- Material Separation13
- Break1
- Device Fell1
Patient problems
- No Clinical Signs, Symptoms or Conditions26
- Insufficient Information5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2026Material Separation
THE CUSTOMER REPORTED THAT DURING VITRECTOMY SURGERY, AN OPHTHALMIC CANNULA TIP FELL OFF. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE PRODUCT. THERE WAS NO PATIENT IMPACT. THIS COMPLAINT IS PERTAINING THE FIRST TIME RECEIVED FROM THE INITIAL REPORTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24471334 ↗MalfunctionSep 18, 2025Material Separation; Material Separation
THE NURSE REPORTED THAT DURING VITRECTOMY SURGERY MISSING SOFT TIP. THERE WAS NO PATIENT HARM
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23082910 ↗MalfunctionSep 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A CUSTOMER REPORTED THAT DURING SURGERY, OPHTHALMIC CANNULA WAS FOUND TO BE FAULTY, AND IT FALLS OFF THE CANNULA IN THE PATIENT EYE. PROCEDURE DETAILS AND PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION HAS BEEN RECEIVED INDICATING SCHEDULED PROCEDURE WAS PARS PLANA VITRECTOMY, MEMBRANE PEEL WITH GAS EXCHANGE OF RIGHT EYE. SOFT TIP REMOVED WITH FORCEPS AND PROCEDURE WAS COMPLETED ON THE SAME DAY WITH NO OTHER ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23072917 ↗MalfunctionAug 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A CUSTOMER REPORTED THAT DURING SURGERY SOFT TIP FALL OFF OF THE OPHTHALMIC CANNULA IN THE PATIENT EYE. PROCEDURE DETAILS AND PATIENT DETAILS WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED INDICATING DURING THE RETINAL PROCEDURE THE SOFT TIP FELL OF AND INTO THE PATIENTS EYE, THE SURGEON WAS ABLE TO REMOVE THE TIP WITH FORCEPS WITH NO HARM TO THE PATIENT. THE SURGERY WAS COMPLETED ON THE SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22814013 ↗MalfunctionJul 29, 2025Material Separation; Material Separation
A CUSTOMER REPORTED THAT AN OPHTHALMIC SOFT TIP WAS NO LONGER ATTACHED TO THE END OF THE CANNULA DURING VITREORETINAL SURGERY. THE PIECE WAS LOCATED AND RETRIEVED WITHOUT ISSUE, THE SURGERY WAS COMPLETED, AND THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22641274 ↗InjuryJul 16, 2025Material Separation; Material Separation
A HEALTHCARE PROFESSIONAL REPORTED THAT SOFT TIP SILICON FELL INSIDE THE EYE DURING VITREO-RETINAL SURGERY. THE SURGERY WAS COMPROMISED TO REMOVE THE BROKEN SILICON TIP FROM EYE WITH FORCEPS VIA SCLERAL INCISION WHICH CAUSED A DELAY IN SURGERY AND INCREASED LENGTH IN SURGICAL TIME. EXTRA INCISION WAS PERFORMED TO REMOVE THE BROKEN SILICON WHERE THE INCISION WAS FOUND TO BE LARGER WOUND AND REQUIRED SUTURES. THE PROCEDURE WAS COMPLETED ON SAME DAY. THE CURRENT PATIENT CONDITION WAS RESOLVED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 22520267 ↗InjuryJul 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A NURSE REPORTED THAT THE OPHTHALMIC SOFT TIP SILICONE DISLODGED DURING VITREORETINAL SURGERY WHILE INSIDE THE EYE. SURGERY WAS COMPROMISED TO REMOVE BROKEN SILICON TIP FROM EYE. THE PATIENT CURRENT CONDITION WAS RESOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22508617 ↗MalfunctionMay 23, 2025Material Separation; Material Separation
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING SURGERY, THE SILICONE TIP OF THE OPHTHALMIC CANNULA FREQUENTLY DETACHED AND WAS FOUND IN THE PATIENT¿S EYE. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; NONE HAS BEEN RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 22076806 ↗MalfunctionApr 25, 2025Break; Break
A CUSTOMER REPORTED THAT DURING SURGERY SOFT TIP OF AN OPHTHALMIC CANNULA BROKE OFF IN PATIENT¿S EYE. THE BROKEN PIECE WAS REMOVED FROM EYE. THE PROCEDURE AND PATIENT DETAILS WERE NOT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21907385 ↗MalfunctionFeb 11, 2025Material Separation; Material Separation
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, THE OPHTHALMIC SOFT TIP CAME OFF AS THE TIP WAS INTRODUCED INTO THE VITREOUS CAVITY. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21353086 ↗MalfunctionDec 6, 2024Material Separation; Material Separation
A CUSTOMER REPORTED THAT DURING VITRECTOMY SURGERY, AN OPHTHALMIC CANNULA¿S FRONT TIPS WERE LOOSENED. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20861993 ↗MalfunctionDec 6, 2024Material Separation; Material Separation
A CUSTOMER REPORTED THAT DURING VITRECTOMY SURGERY, AN OPHTHALMIC CANNULA¿S FRONT TIPS WERE LOOSENED. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20861992 ↗MalfunctionDec 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING VITRECTOMY SURGERY, AN OPHTHALMIC SILICONE TIP DETACHED IN SOME CASES. THE SURGERY WAS COMPLETED, AND THE DETACHED SILICONE PART HAD TO BE REMOVED. NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20820091 ↗MalfunctionNov 11, 2024Material Separation; Material Separation
A CUSTOMER REPORTED THAT AN OPHTHALMIC SILICONE TIP FELL OF THE METAL PORTION OF THE CANNULA PRIOR TO INSERTION INTO THE TROCAR. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20660333 ↗MalfunctionSep 26, 2024Material Separation; Material Separation
A NURSE REPORTED THAT DURING VITRECTOMY SURGERY, AN OPHTHALMIC SILICONE TIP DETACHED INSIDE THE PATIENT¿S EYE, CAUSING A DELAY IN THE PROCEDURE. THE TIP WAS REMOVED BY IRRIGATION, AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY. NO PATIENT IMPACT WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 20307242 ↗MalfunctionApr 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
A NURSE REPORTED THAT AN OPHTHALMIC SOFT TIP CANNULA HAD CAME OFF IN THE EYE DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY. DETAILS OF PATIENT HARM WAS NOT REPORTED.
Patient problems: Insufficient Information
MAUDE report 19097053 ↗MalfunctionMar 21, 2024Material Separation; Material Separation
A NURSE REPORTED THAT DURING A VITRECTOMY SURGERY SILICONE TIP OF AN OPHTHALMIC CANNULA WAS LOST INSIDE PATIENTS LEFT EYE. TIP WAS REMOVED FROM THE EYE IN SAME SURGERY WHICH EXTENDED THE SURGERY BY AN HOUR. SURGERY WAS COMPLETED WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18948071 ↗MalfunctionNov 6, 2023Material Separation; Material Separation
A CUSTOMER REPORTED THAT A SOFT TIP OF AN OPHTHALMIC CANNULA WAS LOOSE. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18071078 ↗MalfunctionOct 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
A NURSE REPORTED THAT DURING THE CATARACT VITRECTOMY COMBINED SURGERY THE SOFT TIP OF AN OPHTHALMIC EXTRUSION CANNULA BECAME DETACHED AND WAS REMOVED FROM THE PATIENT'S EYE. THE SURGERY WAS COMPLETED AND THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18002948 ↗MalfunctionSep 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
A CUSTOMER REPORTED THAT THE SOFT TIP WAS FELL OUT OF THE INSTRUMENT DURING A PARS PLANA VITRECTOMY (PPV) IN THE LEFT EYE. THE PATIENT IMPACT WAS NOT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17834310 ↗MalfunctionAug 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
A PHYSICIAN REPORTED THAT DURING A CATARACT SURGERY AN OPHTHALMIC SOFT TIP FELL OFF IN PATIENTS EYE AND REMOVED PARTICLES BY USING FORCEPS. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED NONE RECEIVED TILL DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17601713 ↗MalfunctionAug 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY AN OPATHALMIC OPERATING SURGICAL CANNULA WAS USED TO REMOVE BASIC SALT SOLUTION FROM THE PATIENT EYE BUT THE SOFT TIP CAME OFF WHEN IT WAS TAKEN FROM THE OPATHALMIC TROCAR CANNULA. DETACHED PARTICLES ARE REMOVED FROM EYE BY USING FORCEPS. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17509401 ↗MalfunctionAug 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY AN OPATHALMIC OPERATING SURGICAL CANNULA WAS USED TO REMOVE BASIC SALT SOLUTION FROM THE PATIENT EYE BUT THE SOFT TIP CAME OFF WHEN IT WAS TAKEN FROM THE OPATHALMIC TROCAR CANNULA. METAL PARTICLES MAY HAVE BEEN RETAINED IN THE EYE.THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17451022 ↗MalfunctionAug 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY AN OPATHALMIC OPERATING SURGICAL CANNULA WAS USED TO REMOVE BASIC SALT SOLUTION FROM THE PATIENT EYE BUT THE SOFT TIP CAME OFF WHEN IT WAS TAKEN FROM THE OPATHALMIC TROCAR CANNULA. METAL PARTICLES MAY HAVE BEEN RETAINED IN THE EYE.THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17451015 ↗MalfunctionMay 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
A CUSTOMER REPORTED THAT AN OPHTHALMIC CANNULA SOFT TIP WAS ABSENT AFTER THE SURGERY. IT WAS UNKNOWN WHETHER IT IS RETAINED IN THE PATIENT EYE OR NOT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16940744 ↗
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- Visitec® 585278Beaver-Visitec International, Inc. · Cannula, Ophthalmic1 recall0 reports
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- Vortex Surgical Inc VS0250.25Vortex Surgical, 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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