SatinSlit® 8065992561Recalls & reported problems
Alcon Laboratories, Inc. · SatinSlit® Knife 2.5mm Angled · Class 1
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380659925610), received between Mar 25, 2024 and Mar 25, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Material Puncture/Hole” (1 report).
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-2664-2024 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Material Puncture/Hole1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 25, 2024Material Puncture/Hole; Material Puncture/Hole
A HEALTHCARE PROFESSIONAL REPORTED THAT OPHTHALMIC SURGICAL BLADE HAD PUNCTURE THROUGH THE FOAM PACKAGING AND THE OPERATOR HAD A STAB INJURY UPON OPENING BEFORE CATARACT SURGERY WHICH WAS TREATED WITH BASIC FIRST AID. THE SURGERY WAS COMPLETED ON THE SAME DAY. THE PATIENT IMPACT WAS NOT REPORTED.
Patient problems: Insufficient Information
MAUDE report 18976339 ↗
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.