Alcon 8065149525Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00380651495258), received between Aug 19, 2021 and Feb 5, 2025 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 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.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2025Material Separation; Material Separation

  A CUSTOMER REPORTED THAT AN OPHTHALMIC SOFT TIP DETACHED FROM THE METAL JUNCTION DURING SURGERY. THE DETACHED SOFT TIP WAS SAFELY REMOVED USING FORCEPS. 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 21312246 ↗
• MalfunctionJul 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A NURSE REPORTED THAT BEFORE A VITRECTOMY SURGERY AN OPHTHALMIC CANNULA SILICONE TIP WAS MISSING FROM THE TIP OF SOFT TIP. PROCEDURE WAS COMPLETED ON SAME DAY. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17368958 ↗
• MalfunctionJul 12, 2023Fitting Problem; Detachment of Device or Device Component; Fitting Problem; Detachment of Device or Device Component

  A NURSE REPORTED THAT DURING THE VITRECTOMY SURGERY, OPHTHALMIC TROCAR COULD NOT BE INSERTED AND THE SOFT TIP BECAME DETACHED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17304103 ↗
• MalfunctionJun 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A NURSE REPORTED THAT BEFORE A PARS PLAN VITRECTOMY SURGERY OPHTHALMIC CANNULA SILICONE TIP WAS MISSING FROM THE TIP. PROCEDURE WAS COMPLETED ON SAME DAY AFTER REPLACING WITH NEW ONE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17171988 ↗
• MalfunctionJun 1, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC TIP WAS FOUND TO BE LEAK FROM JUNCTION OF SILICON AND NEEDLE. THE SURGERY WAS COMPLETED WITH NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17036110 ↗
• MalfunctionMar 15, 2023Fitting Problem; Material Twisted/Bent; Fitting Problem; Material Twisted/Bent

  A CUSTOMER REPORTED THAT OPHTHALMIC CANNULA TIP WAS BENT AND WOULD NOT GO INTO THE PORT DURING A VITRECTOMY SURGERY. 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 16544021 ↗
• InjuryFeb 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A LITERATURE FILE STATED ENLARGEMENT OF PREEXISTING RETINAL BREAK AND MILD TEMPORARY HEMORRHAGE OF THE PATIENTS' EYE DURING FLUID AIR EXCHANGE MODE. THE RETINAL BREAK REQUIRED ADDITIONAL LASER, SCLERAL SUTURES AND SCLEROTOMY. CURRENT CONDITION OF PATIENTS' WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding; Retinal Tear

  MAUDE report 16425739 ↗
• MalfunctionJan 18, 2023Obstruction of Flow; Obstruction of Flow

  A HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC CANNULA (TWO) WAS OBSTRUCTED DURING A VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED WITHOUT PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16194192 ↗
• MalfunctionJan 9, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A CUSTOMER REPORTED THAT DURING CATARACT SURGERY OPHTHALMIC CANNULA HA NO SILICON TIP. PROCEDURE WAS COMPLETED WITH ANOTHER TIP. PATIENT HARM WAS NO REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16121745 ↗
• MalfunctionSep 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  A CUSTOMER REPORTED THAT AN OPHTHALMIC SOFT TIP CANNULA WAS BEING USED TO INJECT INTRAVITREAL CORTICOSTEROID INJECTION INTO THE PATIENT'S EYE DURING A SURGERY. THE TIP WAS TRIMMED AND IT WAS PRIMED PRIOR TO USE. WHILE INJECTING, THE SOFT TIP PORTION OF THE CANNULA WAS EJECTED INTO THE EYE AND WAS SUBSEQUENTLY REMOVED FROM THE EYE DURING THE SAME PROCEDURE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15462173 ↗
• MalfunctionJan 24, 2022Particulates; Detachment of Device or Device Component; Particulates; Detachment of Device or Device Component

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE SILICONE SLEEVE OF OPHTHALMIC CANNULA CAME OFF INTO THE PATIENT'S EYE DURING A VITREO-RETINAL PROCEDURE. THE PIECE OF THE SLEEVE WAS RETAINED IN THE EYE AS THE SURGEON WAS UNABLE TO REMOVE IT. THERE WAS NO FURTHER TREATMENT OR PROCEDURES SCHEDULED. ADDITIONAL INFORMATION HAS BEEN REQUESTED NONE RECEIVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13330860 ↗
• MalfunctionJan 5, 2022Particulates; Detachment of Device or Device Component; Particulates; Detachment of Device or Device Component

  A PHYSICIAN REPORTED THAT DURING A VITRECTOMY PROCEDURE THE PROTECTED OPHTHALMIC SILICON NEEDLE TIP GOT DETACHED INSIDE THE VITREOUS CHAMBER. THE TIP FRAGMENT REMAINED IN THE POSTERIOR CHAMBER OF THE LEFT EYE AND COULD NOT BE FOUND. THE PROCEDURE WAS COMPLETED AND THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13168546 ↗
• MalfunctionNov 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION HAS BEEN RECEIVED CLARIFYING THAT THERE WAS NO PATIENT HARM AND NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12879699 ↗
• MalfunctionAug 19, 2021Fitting Problem; Fitting Problem

  A NURSE REPORTED THAT DURING CATARACT SURGERY THE SOFT TIP EXTRUSION CANNULAS WERE STUCK IN MID SHAFT OF THE TROCARS AND THEY SEEMS TO BE ROUGH IN THAT SECTION OF THE CANNULA OR NOT QUITE STRAIGHT. THE PROCEDURE WAS COMPLETED BY USING OTHER CANNULA. THE PATIENT HARM WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12342318 ↗