The Recall Desk
HighFDA (Devices)·Z-2656-2024·Announced 2024-08-28

Ophthalmic Surgical Knives Recalled Due to Sharpness Issues

Alcon Research LLC is recalling certain ophthalmic knives (20 Gauge V-Lance model) due to complaints about sharpness. The affected units may not function properly during eye surgery.

What this means for you

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 a Class II recall for a surgical instrument with a sharpness defect that could affect surgical performance. No illnesses or injuries have been reported, making the hazard theoretical and placing it in the High category per the rubric.

Plain-English summary

Alcon Research LLC is recalling the 20 Gauge V-Lance Knife (Model 8065912001), an ophthalmic surgical knife. The recall affects approximately 39,954 units.

The recall was initiated after Alcon detected an increase in complaint reports related to sharpness for specific variants including the ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance knives. Complaints regarding sharpness may indicate a defect that could affect proper surgical performance.

The affected units have been distributed nationwide in the United States and internationally. Units were distributed under lot numbers 15W9CJ, 161A10, 161A2M, 163701, 164WWX, and 16D4VU. Healthcare facilities and surgical centers should verify their inventory against these lot numbers.

Those with affected products should contact Alcon Research LLC for guidance regarding their specific units.

The recalled product

Product
Product Desc: Product Name: 20 Gauge V-Lance Knife Model/Catalog Number: 8065912001 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Manufacturer
Alcon Research LLC
Category
Medical Device — Ophthalmic Surgical Instrument
Hazard
Affected units
39,954

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 (8)

  • Model/Catalog Number: 8065912001
  • UDI-DI: 00380659120015
  • Lot numbers: 15W9CJ
  • 161A10
  • 161A2M
  • 163701
  • 164WWX
  • 16D4VU.

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 →

Related recalls

Same manufacturer · Alcon Research LLC

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Same hazard · blade sharpness defect

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