Alcon 8065912501Recalls & reported problems
Alcon Laboratories, Inc. · MVR Knife 25 Gauge · Class 1
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00380659125010), received between Apr 19, 2023 and Jun 4, 2026 — classified as 21 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (13 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.
Reports received per month
Most reported problems
Device problems
- Dull, Blunt13
- Inadequacy of Device Shape and/or Size6
- Material Twisted/Bent3
- Appropriate Device Problem Term/Code Not Available1
- Defective Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- Insufficient Information6
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 4, 2026Appropriate Device Problem Term/Code Not Available
A PHYSICIAN REPORTED THAT BEFORE THE SURGERY AN OPHTHALMIC KNIFE SIZE WAS FOUND TO BE LARGE. THE DETAILS OF THE PROCEDURE AND PATIENT HEALTH IMPACT HAVE NOT BEEN REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25391671 ↗MalfunctionFeb 13, 2026Dull, Blunt
A CUSTOMER REPORTED THAT BEFORE SURGERY AT THE TIME OF OPENING, THE TIP OF AN OPHTHALMIC KNIFE WAS BENT. THE PROCEDURE DETAILS WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24332257 ↗MalfunctionJan 19, 2026Inadequacy of Device Shape and/or Size; Dull, Blunt
A PHYSICIAN REPORTED THAT THE TIP WAS WIDE DURING SURGERY. DETAILS OF THE PROCEDURE AND THE IMPACT ON THE PATIENT WERE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24109122 ↗MalfunctionJan 12, 2026Dull, Blunt
A CUSTOMER REPORTED THAT AN OPHTHALMIC TIP WAS BENT WHEN VIEWED UNDER A MICROSCOPE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THE PATIENT IMPACT HAS NOT BEEN REPORTED.
Patient problems: Insufficient Information
MAUDE report 24033908 ↗MalfunctionDec 12, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
A CUSTOMER REPORTED THAT DURING VITREORETINAL SURGERY, THE OPHTHALMIC BLADE WAS FOUND TO BE MISSHAPEN. IT APPEARED TAPERED AT THE MID-SHAFT AND DID NOT FIT INTO THE TROCAR. PRODUCT DETAILS WERE NOT PROVIDED. THE SURGEON REMOVED THE BLADE AND OPENED A NEW ONE, WHICH FIT AS EXPECTED THROUGH THE TROCAR. THERE WAS NO IMPACT ON THE PATIENT, ONLY A BRIEF DELAY IN EXCHANGING THE PRODUCT DURING THE PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23788624 ↗MalfunctionDec 11, 2025Inadequacy of Device Shape and/or Size; Dull, Blunt; Inadequacy of Device Shape and/or Size; Dull, Blunt
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE ISSUE WAS RELATED TO A THICK SHANK IN THE OPHTHALMIC KNIFE.
Patient problems: Insufficient Information
MAUDE report 23777133 ↗MalfunctionDec 9, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
A PHYSICIAN REPORTED THAT DURING SURGERY, AN OPHTHALMIC KNIFE WAS TOO THICK AND DID NOT PASS THROUGH THE CANNULA. THE SURGERY WAS COMPLETED ON THE SAME DAY. THE PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE HAS BEEN RECEIVED TO DATE.
Patient problems: Insufficient Information
MAUDE report 23755498 ↗MalfunctionDec 3, 2025Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT DURING VITRECTOMY SURGERY, AN OPHTHALMIC KNIFE DID NOT ENTER THE TROCAR. THE SURGERY WAS COMPLETED ON THE SAME DAY, AND NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT HAS NOT BEEN RECEIVED TO DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23704402 ↗MalfunctionDec 2, 2025Defective Component; Dull, Blunt; Defective Component; Dull, Blunt
A PHYSICIAN REPORTED BEFORE SURGERY, AN OPHTHALMIC CUTTING INSTRUMENT TIP WAS BENT AND COULD NOT BE INSERTED INTO TROCAR. THE SURGERY WAS COMPLETED ON THE SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23692776 ↗MalfunctionNov 21, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
A PHYSICIAN REPORTED THAT THE SHAFT OF AN OPHTHALMIC KNIFE WAS TOO THICK IN THE MIDDLE TO ENTER A CANNULA DURING SURGERY. THE SURGERY WAS COMPLETED THE SAME DAY AFTER REPLACING THE KNIFE WITH ANOTHER ONE, AND THERE WAS NO IMPACT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23613544 ↗MalfunctionOct 23, 2025Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT BEFORE CATARACT AND VITRECTOMY COMBINATION SURGERY, AN OPHTHALMIC CUTTING KNIFE WAS FOUND TO BE BENT. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23365195 ↗MalfunctionSep 11, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
A PHYSICIAN REPORTED THAT AN OPHTHALMIC BLADE COULD NOT GET INTO A CANNULA BECAUSE OF ITS THICKNESS DURING SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PROCEDURE TYPE IS UNKNOWN. THE INVOLVED EYE AND THE PATIENT IDENTIFIER ARE NOT AVAILABLE. THERE'S NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23024015 ↗MalfunctionSep 9, 2025Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT BEFORE VITRECTOMY SURGERY, THE OPHTHALMIC KNIFE WAS FOUND BENT. 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 23005301 ↗MalfunctionAug 26, 2025Material Twisted/Bent; Material Twisted/Bent
A PHYSICIAN REPORTED THAT DURING THE VITRECTOMY SURGERY AN OPHTHALMIC KNIFE TIP WAS BENT AND COULD NOT BE INSERTED INTO A PORT FOR VITREOUS PROCEDURE. IT IS UNKNOWN WHETHER THE SURGERY WAS COMPLETED OR NOT. PATIENT IMPACT HAVE NOT BEEN REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 22897480 ↗MalfunctionAug 26, 2025Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT DURING SURGERY INCISIONAL INSTRUMENT TIP WAS THICKER THAN USUAL. 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 22893413 ↗MalfunctionAug 25, 2025Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT BEFORE SURGERY INCISIONAL INSTRUMENT WAS BENT WHEN OPENED. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22882131 ↗MalfunctionAug 22, 2025Material Twisted/Bent; Material Twisted/Bent
A PHYSICIAN REPORTED THAT THE BLADE WAS FOUND TO BE BENT WHEN OPENING THE PACK BEFORE SURGERY. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE PROCEDURE TYPE IS UNKNOWN AND NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22871273 ↗MalfunctionAug 19, 2025Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT BEFORE SURGERY, AN OPHTHALMIC INCISIONAL INSTRUMENT WAS BENT WHEN OPENED. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22837165 ↗MalfunctionAug 13, 2025Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT THE BLADE OF THE V-LANCE WAS FOUND BENT WHEN OPENED BEFORE SURGERY. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE.
Patient problems: Insufficient Information
MAUDE report 22792514 ↗MalfunctionJun 27, 2024Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT DURING VITRECTOMY SURGERY IT WAS FOUND THAT BLADE WAS NOT SHARP AND THE INCISION CANNOT PENETRATE WELL. PATIENT IMPACT WAS NOT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19627464 ↗MalfunctionApr 19, 2023Material Twisted/Bent; Material Twisted/Bent
A PHYSICIAN REPORTED THAT DURING CATARACT VITRECTOMY AN OPHTHALMIC OPERATING KNIVES TIP WAS BENT. PROCEDURE WAS COMPLETED USING ANOTHER PRODUCT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16766549 ↗
Other Knife, ophthalmic devices
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- ClearCut®; Intrepid 8065992445Alcon Laboratories, Inc. · Knife, ophthalmic2 recalls170 reports
- ClearCut®; Intrepid 8065982465Alcon Laboratories, Inc. · Knife, ophthalmic1 recall153 reports
- V-Lance 8065912001Alcon Laboratories, Inc. · Knife, ophthalmic2 recalls68 reports
- ClearCut® 8065771541Alcon Laboratories, Inc. · Knife, ophthalmic2 recalls38 reports
- ClearCut® 8065771540Alcon Laboratories, Inc. · Knife, ophthalmic2 recalls30 reports
- ClearCut®; Intrepid 8065772465Alcon Laboratories, Inc. · Knife, ophthalmic2 recalls7 reports
- ClearCut®; Intrepid 8065982265Alcon Laboratories, Inc. · Knife, ophthalmic104 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.