Alcon 8065149530Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00380651495302), received between Jan 5, 2021 and Sep 17, 2026 — classified as 4 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Fitting Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Fitting Problem

  A customer reported that, during the vitrectomy procedure, the ophthalmic tip had an issue with a flute instrument that could not be inserted through the trocar as intended. The procedure was completed using an alternative flute instrument. There was no patient injury

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50798810 ↗
• InjuryFeb 20, 2026Material Separation

  A CUSTOMER REPORTED THAT DURING RETINAL SURGERY SURGEON WAS USING A SOFT TIP CANNULA WHILE PLACING DYE IN THE EYE. AS HE PUSHED THE PLUNGER ON THE SYRINGE, THE CENTER PIECE OF THE CANNULA WAS RELEASED AND ENTERED THEY EYE AND CAME TO REST AGAINST THE POSTERIOR ASPECT OF THE EYE. PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE PIECE OF THE CANNULA THAT CAME LOOSE WAS REMOVED BY THE SURGEON AND THE PROCEDURE WAS FINISHED BY AN INCISION WAS MADE TO THE SCLERA AND A FORCEPS WAS USED TO RETRIEVE THE PIECE OF CANNULA. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24399335 ↗
• MalfunctionOct 30, 2025Fitting Problem; Fitting Problem

  A CUSTOMER REPORTED THAT AN OPHTHALMIC TIP DID NOT ENTER INTO THE TROCAR DURING A VITRECTOMY SURGERY. PATIENT DETAILS AND PATIENT IMPACT IS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE RECEIVED TILL DATE.

  Patient problems: Insufficient Information

  MAUDE report 23426098 ↗
• MalfunctionOct 29, 2025Material Separation; Material Separation

  A PHYSICIAN REPORTED THAT DURING SURGERY ON THE PATIENT'S RIGHT EYE, THE SILICONE TUBE IN AN OPHTHALMIC SILICONE TIP HAD COME LOOSE IN THE VITREOUS BODY AND WAS REMOVED WITH TWEEZERS. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH A SLIGHT DELAY, AND THERE WAS NO HARM TO THE PATIENT. THE PATIENT'S CONDITION HAD RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23411103 ↗
• MalfunctionOct 24, 2025Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT DURING MACULAR PUCKER SURGERY OPHTHALMIC SOFT TIP FALL OFF IN THE EYE AND THE SOFT TIP WAS RETRIEVED FROM THE EYE WITH A DISPOSABLE FORCEPS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23378474 ↗
• MalfunctionSep 11, 2025Material Disintegration; Material Disintegration

  A PHYSICIAN REPORTED THAT SILICONE TIP FELL INTO EYE. THE PROCEDURE AND PATIENT DETAILS WERE NOT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23026464 ↗
• MalfunctionSep 10, 2025Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT DURING SURGERY, THEY WERE UNABLE TO INSERT THE OPHTHALMIC CANNULA. THE SURGERY WAS COMPLETED BY USING ALTERNATIVE CANNULA AND THERE WAS NO PATIENT HARM. PROCEDURE DETAILS HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; NONE HAS BEEN RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23015276 ↗
• MalfunctionApr 29, 2025Obstruction of Flow; Obstruction of Flow

  A NURSE REPORTED THAT DURING A VITRECTOMY SURGERY AN OPHTHALMIC CANNULA WAS OBSTRUCTED. THE SURGERY WAS COMPLETED ON SAME DAY.

  Patient problems: Insufficient Information

  MAUDE report 21926295 ↗
• MalfunctionMar 20, 2025Fitting Problem; Fitting Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC SILICONE CANNULA DID NOT FIT THROUGH THE TROCAR. THE SURGERY WAS COMPLETED ON THE SAME DAY. THE OTHER PROCEDURE DETAILS HAVE NOT BEEN PROVIDED. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21649862 ↗
• MalfunctionFeb 18, 2025Fitting Problem; Fitting Problem

  A NURSE REPORTED THAT DURING VITRECTOMY SURGERY, THE PHYSICIAN HAD SIGNIFICANT DIFFICULTY INSERTING THE SOFT-TIP CANNULA INTO THE PORT. THE PHYSICIAN CUT OFF A BIT OF THE TIP TO GET IT INTO THE PORT, BUT WHEN USING THE CUTTER, THE PORT DETACHED FROM THE SHAFT OF THE CUTTER. IT WAS ALSO REPORTED THAT WHEN THE PHYSICIAN SWITCHED TO ANOTHER SOFT-TIP CANNULA, AGAIN UNABLE TO INSERT THE TIP INTO THE PORT AND HAD TO OPEN ANOTHER NEW CANNULA. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING WITH ANOTHER NEW CANNULA WITH GREAT DIFFICULTY. PATIENT IMPACT HAS NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.

  Patient problems: Insufficient Information

  MAUDE report 21404165 ↗
• MalfunctionJan 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A NURSE REPORTED THAT DURING A VITRECTOMY SURGERY, THE SILICONE TIP BECAME DISLODGED AND SLIPPED OFF OF THE CANNULA. THE SILICONE TIP REMAINED IN THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATED THAT THE SOFT TIP WAS NOT RETAINED IN THE EYE AND REMOVED DURING THE SAME PROCEDURE. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21158894 ↗
• MalfunctionJun 26, 2024Break; Break

  A CUSTOMER REPORTED THAT AN OPHTHALMIC CANNULA HAD AN ISSUE WITH SOFT TIP CANNULA AND CANNULA CAME LOOSE WHILE USING THE CANNULA IN THE EYE DURING THE COMBINATION OF VITRECTOMY AND CATARACT PROCEDURE. THERE IS NO PATIENT IMPACT.

  Patient problems: Insufficient Information

  MAUDE report 19621176 ↗
• MalfunctionMay 27, 2024Material Separation; Material Separation

  A NURSE THAT DURING VITRECTOMY PROCEDURE, AN OPHTHALMIC TIP ON THE NEEDLE POPPED OFF IN PATIENT EYE. IT WAS FURTHER REPORTED THAT THE TIP WAS RETRIEVED FROM THE PATIENT EYE. THERE WAS NO PATIENT IMPACT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19400419 ↗
• MalfunctionMar 27, 2024Material Separation; Material Separation

  A CUSTOMER REPORTED THAT DURING A PHACOVITRECTOMY, INVERTED FLAP TECHNIQUE FOR MACULAR HOLE CLOSURE SURGERY AN OPHTHALMIC SURGICAL SOFT TIP WAS PROLAPSED INTO THE VITREOUS BODY (EYE UNKNOWN) . THE TIP WAS REMOVED DURING SAME SURGERY AND THE SURGERY WAS COMPLETED ON THE SAME DAY WITH EXTENDED DURATION OF PROCEDURE WITH NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18985161 ↗
• MalfunctionFeb 16, 2024Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent

  A CUSTOMER REPORTED THAT DURING A VITRECTOMY RETINAL SURGERY TIP WAS LOOSE AND CANNULA WAS BENT WHICH COULD NOT BE USED. THE SURGERY WAS COMPLETED. THERE WAS NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18719248 ↗
• MalfunctionJan 30, 2024Fitting Problem; Fitting Problem

  A CUSTOMER REPORTED THAT DURING SET UP FOR CATARACT VITRECTOMY COMBINATION OF THE SURGERY AN OPHTHALMIC OPERATING SURGICAL SOFT TIP OF CANNULA DID NOT FIT INTO THE TROCAR TO PERFORM THE INFUSION. PROCEDURE WAS COMPLETED BY REPLACING THE TIP AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18603985 ↗
• MalfunctionJan 10, 2024Fitting Problem; Fitting Problem

  A CUSTOMER REPORTED THAT OPHTHALMIC SOFT TIPS WERE NOT FITTING INTO TROCARS. PATIENT AND PROCEDURE WERE NOT REPORTED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18483921 ↗
• MalfunctionNov 9, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A CUSTOMER REPORTED THAT AN OPHTHALMIC OPERATING SOFT TIP CANNULA WAS FELL OFF INTO THE PATIENT LEFT EYE DURING THE VITRECTOMY PROCEDURE. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REMOVING THE TIP WITH HELP OF THE FORCEPS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18099046 ↗
• MalfunctionOct 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A CUSTOMER REPORTED THAT THE STAIN WAS INJECTED THROUGH OPHTHALMIC SOFT TIP, AND IT EJECTED THE ACTUAL SOFT TIP OUT OF THE CANNULA INTO THE BACK OF THE EYE WHERE THE SURGEON SUCCESSFULLY RETRIEVED USING A PAIR OF FORCEPS. THE PROCEDURE DETAILS WERE NOT REPORTED. THERE WAS NO PATIENT IMPACT, AND THE TIP WAS SUCCESSFULLY RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17995177 ↗
• InjuryOct 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A VITRECTOMY SURGERY THE TIP CAME OFF THE METAL SHAFT AND DISLODGED INTRA-OCULARLY. THE SURGEON WAS ABLE TO RETRIEVE IT WITH FORCEPS AND IT CAME OUT AND SURGERY WAS COMPLETED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION RECEIVED INDICATED THAT AFTER REMOVAL OF THE TIP FROM LEFT EYE AS HERE WAS RETINAL CONTUSION SUPERIOR TO THE MACULAR HOLE FROM THE IMPACT OF THE SILICONE TIP DISLODGING INTO THE EYE DURING INJECTION AND PATIENT EXPERIENCED RETINAL HEMORRHAGE AND LENS OPACIFICATION WHICH REQUIRED SURGICAL INTERVENTION.

  Patient problems: Corneal Clouding/Hazing; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17878111 ↗
• MalfunctionSep 25, 2023Fitting Problem; Fitting Problem

  A CUSTOMER REPORTED THAT DURING A SURGERY AN OPHTHALMIC CANNULA WAS NOT GETTING INTO THE SOFT TIP. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17807913 ↗
• MalfunctionSep 8, 2023Fitting Problem; Fitting Problem

  A PHARMACIST REPORTED THAT OPHTHALMIC CANNULA TIP WAS UNEVEN AND IT COULD NOT FIT INTO THE TUBE DURING VITRECTOMY SURGERY. THERE WAS NO PATIENT HARM AND PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17711416 ↗
• MalfunctionJul 13, 2023Fitting Problem; Fitting Problem

  A CUSTOMER REPORTED THAT DURING VITRECTOMY SURGERY AN OPHTHALMIC OPERATING SURGICAL CANNULA COULD NOT INSERT INTO THE OPHTHALMIC TROCAR. PROCEDURE WAS COMPLETED AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17313660 ↗
• MalfunctionJul 11, 2023Fitting Problem; Fitting Problem

  A PHARMACIST REPORTED THAT DURING VITRECTOMY SURGERY AN OPHTHALMIC SURGICAL CANNULA COULD NOT BE INSERTED INTO THE TROCAR. PROCEDURE WAS COMPLETED ON THE SAME DAY WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17296415 ↗
• MalfunctionJul 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A SURGERY SILICONE PART REMAINED INSIDE THE SIDE WHICH WAS REMOVED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17265336 ↗