SatinSlit® 8065992761Recalls & reported problems
Alcon Laboratories, Inc. · SatinSlit® Knife 2.75mm Angled · Class 1
All models of SatinSlit (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Alcon SatinSlit ophthalmic knife appears in 39 adverse event reports, all malfunctions, with no deaths or injuries. The reports mainly describe blades that are dull or blunt, occasionally twisted or bent material, during eye surgery, with procedures completed using replacements and no patient harm. One recall is open, started July 2024, about an increase in sharpness complaints for specific knives.
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
- 37
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00380659927614), received between Mar 9, 2021 and Nov 18, 2025 — classified as 37 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (36 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Jul 15, 2024Open, Classified
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
Z-2668-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Dull, Blunt36
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions31
- Insufficient Information6
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 18, 2025Dull, Blunt; Dull, Blunt
THE PHYSICIAN REPORTED THAT DURING VITRECTOMY SURGERY AN OPHTHALMIC CUTTING KNIFE WAS FOUND TO BE DULL. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE'S NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23583035 ↗MalfunctionJul 7, 2025Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC CUTTING KNIFE WAS POOR. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE PRODUCT. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22413476 ↗MalfunctionMar 3, 2025Dull, Blunt; Dull, Blunt
THE PHYSICIAN REPORTED THAT SEVEN OPHTHALMIC KNIVES FROM SAME LOT WERE NOT SHARP ENOUGH. THE PROCEDURE WAS COMPLETED BY REPLACING THE KNIFE. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21511496 ↗MalfunctionDec 2, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT AN OPHTHALMIC CUTTING KNIVES WERE FOUND TO BE DULL WHEN CATARACT SURGERY WAS SCHEDULED. DETAILS OF PROCEDURE WAS NOT REPORTED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20819491 ↗MalfunctionDec 2, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT AN OPHTHALMIC CUTTING KNIVES WERE FOUND TO BE DULL WHEN CATARACT SURGERY WAS SCHEDULED. DETAILS OF PROCEDURE WAS NOT REPORTED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20819311 ↗MalfunctionSep 25, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT DURING SURGERY AN OPHTHALMIC CUTTING KNIVES WAS FOUND BLUNT WITH NO IMPACT ON PATIENT. PROCEDURE DETAILS WAS NOT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20300255 ↗MalfunctionSep 12, 2024Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT THE OPHTHALMIC CUTTING KNIVES WERE FOUND TO BE DULL DURING SURGERY. THE TYPE OF PROCEDURE IS UNKNOWN. THE SURGERY WAS COMPLETED USING A NEW KNIFE FROM A SEPARATE PACKAGE, AND NO PATIENT IMPACT WAS REPORTED. THIS IS THE THIRD OF FIVE REPORTS RECEIVED FROM THE SAME INITIAL REPORTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20200920 ↗MalfunctionSep 10, 2024Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT AN OPHTHALMIC CUTTING KNIFE WAS FOUND TO BE DULL DURING SURGERY. THE SURGERY WAS COMPLETED WITH ALTERNATIVE KNIFE ON THE SAME DAY. THERE WAS NO PATIENT HARM. DETAILS OF SURGERY WAS NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20177853 ↗MalfunctionSep 10, 2024Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT AN OPHTHALMIC CUTTING KNIVES WERE FOUND TO BE DULL DURING SURGERY. THE SURGERY WAS COMPLETED WITH ALTERNATIVE KNIVES ON THE SAME DAY. THERE WAS NO PATIENT HARM. DETAILS OF SURGERY WAS NOT PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20177630 ↗MalfunctionJul 24, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT DURING CATARACT SURGERY THE OPHTHALMIC BLADES WERE FOUND TO BE DULL. THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19819864 ↗MalfunctionJul 22, 2024Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT AN OPHTHALMIC BLADES WERE FOUND TO BE DULL DURING SURGERY. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 19790882 ↗MalfunctionJul 15, 2024Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT THE OPHTHALMIC KNIVES WERE BLUNT. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED . ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 19738968 ↗MalfunctionJul 12, 2024Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT THE OPHTHALMIC KNIVES WERE BLUNT. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 19729248 ↗MalfunctionJun 21, 2024Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT DURING SURGERY IT WAS FOUND THAT KNIVES WERE DULL. USED SLIT KNIFE SEPARATELY AND COMPLETED THE SURGERY WITH NO PATIENT HARM. PROCEDURE DETAILS WAS NOT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19582852 ↗MalfunctionJun 21, 2024Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT DURING SURGERY IT WAS FOUND THAT KNIVES WERE DULL. USED SLIT KNIFE SEPARATELY AND COMPLETED THE SURGERY WITH NO PATIENT HARM. PROCEDURE DETAILS WAS NOT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19582474 ↗MalfunctionJun 21, 2024Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT DURING SURGERY IT WAS FOUND THAT KNIVES WERE DULL. USED SLIT KNIFE SEPARATELY AND COMPLETED THE SURGERY WITH NO PATIENT HARM. PROCEDURE DETAILS WAS NOT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19582092 ↗MalfunctionJun 11, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT AN OPHTHALMIC KNIVES WERE DULL. THE DETAILS OF PROCEDURE AND PATIENT IMPACT WAS NOT REPORTED.
Patient problems: Insufficient Information
MAUDE report 19510335 ↗MalfunctionJun 11, 2024Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT AN OPHTHALMIC KNIFE WAS NOT SHARP DURING SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE PRODUCT. THE DETAILS OF THE SURGERY WAS NOT REPORTED. NO PATIENT IMPACT WAS REPORTED. ADDITIONAL DETAILS HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19509978 ↗MalfunctionJun 11, 2024Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT AN OPHTHALMIC KNIFE WAS NOT SHARP DURING SURGERY. THE SURGERY WAS COMPLETED WITH ALTERNATIVE PRODUCT ON THE SAME DAY. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19509861 ↗MalfunctionJun 11, 2024Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT OPHTHALMIC SLIT KNIFE WAS NOT SHARP DURING SURGERY. ANOTHER SLIT KNIFE THAT IS SINGLE PACKAGED WAS OPENED AND USED, AND THE SURGERY WAS COMPLETED. THE PROCEDURE TYPE WAS UNKNOWN. THE INVOLVED EYE AND THE PATIENT IDENTIFIER WERE NOT AVAILABLE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19509730 ↗MalfunctionJun 11, 2024Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT THE OPHTHALMIC KNIVES WERE NOT SHARP DURING SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE DETAILS OF THE PROCEDURE WAS NOT REPORTED. NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19508479 ↗MalfunctionJun 11, 2024Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT DURING THE CATARACT SURGERY, OPHTHALMIC KNIFE OF TIP WAS NOT SHARP ENOUGH TO PENETRATE. SURGERY HAS BEEN COMPLETED BY NEW BLADE WITHOUT PATIENT IMPACT. THIS FILE IS FOR THE TWO OF THE FOUR INCIDENTS FORM THE INITIAL REPORTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19508172 ↗MalfunctionJun 11, 2024Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT DURING THE CATARACT SURGERY, OPHTHALMIC KNIFE OF TIP WAS NOT SHARP ENOUGH TO PENETRATE. SURGERY HAS BEEN COMPLETED BY NEW BLADE AND WITHOUT PATIENT IMPACT. THIS FILE IS FOR THE THREE OF THE FOUR INCIDENTS FORM THE INITIAL REPORTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19508077 ↗MalfunctionJun 11, 2024Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT DURING THE CATARACT SURGERY, OPHTHALMIC KNIFE OF TIP WAS NOT SHARP ENOUGH TO PENETRATE. SURGERY HAS BEEN COMPLETED BY NEW BLADE AND WITHOUT PATIENT IMPACT. THIS FILE IS FOR THE FOUR OF THE FOUR INCIDENTS FORM THE INITIAL REPORTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19507281 ↗MalfunctionJun 10, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT AN OPHTHALMIC CUTTING KNIVES WERE FOUND TO BE DULL. THE PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED.
Patient problems: Insufficient Information
MAUDE report 19502089 ↗
Other Knife, ophthalmic devices
- ClearCut® 8065921541Alcon Laboratories, Inc. · Knife, ophthalmic2 recalls215 reports
- 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 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 · each recall links to the FDA recall notice
- 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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