SatinCrescent® 8065990002Recalls & reported problems
Alcon Laboratories, Inc. · SatinCrescent® Knife Angled Bevel Up · Class 1
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00380659900020), received between Jul 28, 2021 and Sep 30, 2026 — classified as 9 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (7 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. How this data works · Data updated Oct 13, 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-2661-2024 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Dull, Blunt7
- Manufacturing, Packaging or Shipping Problem1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Insufficient Information1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Manufacturing, Packaging or Shipping Problem
A physician reported that, prior to surgery, the outer box of an ophthalmic blade was collapsed when opened. Procedure details and patient impact 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 50948028 ↗MalfunctionAug 22, 2025Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT DURING SURGERY OPHTHALMIC SCALPEL WAS BLUNT. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE PRODUCT AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22870426 ↗MalfunctionAug 7, 2025Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC SCALPEL WAS FOUND TO BE BLUNT. PROCEDURE DETAILS AND PATIENT IMPACT IS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 22742739 ↗MalfunctionFeb 6, 2025Dull, Blunt; Dull, Blunt
THE PHYSICIAN REPORTED THAT DURING CATARACT SURGERY THE KNIFE WAS DULL AND NOT SHARP. THE SURGERY WAS COMPLETED ON THE SAME DAY WITHOUT PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21319755 ↗MalfunctionApr 10, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT AN OPHTHALMIC SCALPEL WAS FOUND TO BE BLUNT DURING SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE PRODUCT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19079518 ↗MalfunctionNov 9, 2021Dull, Blunt; Dull, Blunt
A NURSE REPORTED THE HEALTH CARE PROFESSIONAL ENCOUNTERED THREE OPHTHALMIC CRESCENT KNIVES WITH BLUNT TIPS WHEN VIEWED UNDER THE MICROSCOPE AND THEY COULD NOT COMPLETE THE PUNCTURE DURING A CATARACT PROCEDURE. THE FOURTH REPLACEMENT KNIFE WAS OBTAINED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12778669 ↗MalfunctionSep 15, 2021Material Fragmentation; Material Fragmentation
A SURGEON REPORTED THAT MULTIPLE KNIVES WERE USED DURING SEPARATE CATARACT SURGERIES WHICH, DURING AND AFTER THE PROCEDURES, DEBRIS WAS NOTED IN THE INCISION SITE WITH VIRTUALLY EVERY BLADE USED. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12474777 ↗MalfunctionJul 28, 2021Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT MULTIPLE KNIVES WERE BLUNT DURING SEPARATE CATARACT SURGERIES. THERE WAS NO REPORT OF ANY PATIENT HARM. THE ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT CONFIRMED THAT AN ALTERNATE KNIFE WAS OBTAINED IN ORDER TO COMPLETE EACH SURGERY. IT WAS FURTHER CONFIRMED THAT THERE WAS NO HARM TO ANY PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12240845 ↗MalfunctionJul 28, 2021Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT MULTIPLE KNIVES WERE BLUNT DURING SEPARATE CATARACT SURGERIES. THERE WAS NO REPORT OF ANY PATIENT HARM. THE ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT CONFIRMED THAT AN ALTERNATE KNIFE WAS OBTAINED IN ORDER TO COMPLETE EACH SURGERY. IT WAS FURTHER CONFIRMED THAT THERE WAS NO HARM TO ANY PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12240843 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.