Alcon 8065149523Recalls & reported problems
Alcon Laboratories, Inc. · Microsurgical Instrument 23GA SOFT TIP NEEDLE · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380651495234), received between Mar 3, 2023 and Dec 18, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component2
- Fitting Problem2
- Obstruction of Flow1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 18, 2025Obstruction of Flow; Obstruction of Flow
A HEALTHCARE PROFESSIONAL REPORTED THAT, AN OPHTHALMIC CANNULA DID NOT PERFORM THE FUNCTION PROPERLY. IT IS UNKNOWN WHETHER THE SURGERY WAS COMPLETED. PROCEDURE DETAILS AND PATIENT HARM WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 23839225 ↗MalfunctionMar 12, 2025Fitting Problem; Fitting Problem
A NURSE REPORTED THAT DURING VITRECTOMY SURGERY AN OPHTHALMIC SOFT TIP NEEDLE DID NOT FIT INTO THE TROCAR. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21583170 ↗MalfunctionFeb 18, 2025Fitting Problem; Fitting Problem
A NURSE REPORTED THAT DURING VITRECTOMY SURGERY AN OPHTHALMIC SOFT TIP NEEDLE DID NOT FIT INTO THE TROCAR. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21397545 ↗MalfunctionAug 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A SURGERY AN OPHTHALMIC TIP WAS CUT OFF INSIDE THE PACKAGING. SURGERY WAS COMPLETED AND PATIENT HARM WAS NOT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17641507 ↗MalfunctionMar 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
A NURSE REPORTED THAT AN OPHTHALMIC CANNULA HAD NO SOFT TIP INSIDE THE PACKAGE DURING PREPARATION OF CATARACT SURGERY. PROCEDURE COMPLETED ON THE SAME DAY. NO PATIENT HARM WAS REPORTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16476961 ↗
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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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