The Recall Desk
HighFDA (Devices)·Z-2645-2024·Announced 2024-08-28

ClearCut S Safety Sideport Knife Recalled for Decreased Sharpness

Alcon Research LLC is recalling ClearCut S Safety Sideport Knife ophthalmic surgical instruments due to reports of decreased sharpness. Affected units may not perform as intended 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 Class II medical device recall involves a surgical instrument where decreased sharpness poses risk of patient harm if it affects surgical performance. Although no illnesses or injuries have been reported, it qualifies as a risk-of-harm product without reported injury per the severity rubric.

Plain-English summary

Alcon Research LLC is recalling specific batches of ClearCut S Safety Sideport Knife 1.0mm Dual Bevel ophthalmic surgical instruments (Model 8065771540). The recall affects approximately 20,034 units distributed nationwide in the United States and internationally.

Alcon has detected an increase in complaint reports related to sharpness of these ophthalmic knives. Instruments with decreased sharpness may not perform as intended during surgical eye procedures.

The affected units can be identified by model number 8065771540 and the following lot numbers: 1668D7, 167PRA, 167PTK, 168NMF, 169KL4, 169KTP, 16ALPE, 16ALTU, 16AV18, 16DDPR, and 16DDRU.

Healthcare providers and surgical facilities using these instruments should contact Alcon directly regarding replacement, repair, or return of affected units.

The recalled product

Product
Product Name: ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalog Number: 8065771540 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Manufacturer
Alcon Research LLC
Category
Medical Device — Ophthalmic Surgery
Hazard
Affected units
20,034

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 (13)

  • Model/Catalog Number: 8065771540
  • UDI-DI: 00380657715404
  • Lot numbers: 1668D7
  • 167PRA
  • 167PTK
  • 168NMF
  • 169KL4
  • 169KTP
  • 16ALPE
  • 16ALTU
  • 16AV18
  • 16DDPR
  • 16DDRU

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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