The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2664-2024·Announced 2024-08-28

Ophthalmic knife sharpness defect recalled for increased complaints

Alcon recalls 3,419 ophthalmic knives due to increased complaints about blade sharpness. The Class II recall affects the ClearCut SB INTREPID 2.2 ANG and related models distributed nationwide and internationally.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a surgical instrument with a functional defect in blade sharpness. Although no illnesses or injuries are reported in the source, the defect poses a risk of harm in surgical settings where blade sharpness is critical to patient safety and surgical outcomes.

Plain-English summary

Alcon Research LLC is recalling 3,419 units of ophthalmic knives due to increased complaint reports related to blade sharpness defects. The affected products include the ClearCut SB INTREPID 2.2 ANG (Model 8065992561, Lot 16ALWU) and related models including the ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance ophthalmic knives.

Ophthalmic knives are precision surgical instruments used during eye surgery to create incisions. Loss of sharpness in the blade could compromise surgical precision and potentially affect surgical outcomes. The FDA has classified this as a Class II recall, indicating serious potential health consequences.

The recalled units were distributed throughout the United States and internationally to more than 40 countries including Canada, Mexico, the United Kingdom, Japan, Australia, and others. Individuals or facilities with these products should contact Alcon Research LLC or their medical device distributor immediately to arrange for replacement or return of affected units.

The recalled product

Product
Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Number: 8065992561 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Manufacturer
Alcon Research LLC
Category
Medical Device — Surgical Instruments / Ophthalmic
Hazard
Affected units
3,419

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Model/Catalog Number: 8065992561
  • UDI-DI: 00380659925610
  • Lot number: 16ALWU.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 36 recalled by Alcon Research LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 36 products in this recall →

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