The Recall Desk
HighFDA (Devices)·Z-1925-2024·Announced 2024-06-05

Ophthalmic surgical knives recalled due to sharpness complaints

Alcon is recalling ClearCut S Safety Sideport Knife (1.2mm Dual Bevel) due to increased reports of sharpness issues. The recall affects 4,930 units distributed worldwide.

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 an FDA Class II medical device recall involving surgical instruments where the identified hazard (loss of sharpness) could impact surgical precision. No hospitalizations, serious injuries, or deaths have been reported, placing this in the 'High' category per the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Alcon Research LLC is recalling the ClearCut S Safety Sideport Knife 1.2mm Dual Bevel (Model 8065771541) ophthalmic surgical knife. This precision instrument is used in eye surgery.

The recall was initiated due to an increase in complaint reports regarding the sharpness of these surgical knives. Approximately 4,930 units have been affected and distributed worldwide, including the United States and over 40 countries.

Standalone sterile knives have been placed on hold. However, knives included in Alcon Custom Pak surgical procedure packs are continuing to be distributed, as Alcon determined that halting distribution would create an immediate market shortage and result in canceled surgeries.

Healthcare providers and facilities that received affected units should be aware of the sharpness concerns when using these knives. For more information about the recall, contact Alcon or refer to FDA recall number Z-1925-2024.

The recalled product

Product
ClearCut S Safety Sideport Knife 1.2mm Dual Bevel Model/Catalog Number: 8065771541 Software Version: N/A Product Description: Ophthalmic Knife Component: N/A
Manufacturer
Alcon Research LLC
Category
Medical Device — Ophthalmic Surgical Instrument
Hazard
Affected units
4,930

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 (5)

  • Model/Catalog Number: 8065771541
  • UDI/DI: 00380657715411
  • Lot/Batch: 168NME
  • 168NND
  • 16AV17

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

Related recalls

Same manufacturer · Alcon Research LLC

See all →