The Recall Desk
HighFDA (Devices)·Z-2666-2024·Announced 2024-08-28

Alcon ophthalmic surgical knives recalled for sharpness defect

Alcon is recalling 145,248 ophthalmic knives (CLEARCUT SATINSLIT model 8065992745) due to increased complaint reports of inadequate sharpness. The surgical instruments were distributed nationwide and internationally.

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: The recalled ophthalmic knives are risk-of-harm medical devices. No injuries or hospitalizations have been reported in the source material. Per the severity rubric, risk-of-harm products where injury has not yet been reported receive a High (3) severity score.

Plain-English summary

Alcon Research LLC is recalling 145,248 units of CLEARCUT SATINSLIT FULL HANDLE 2.75MM AN ophthalmic knives (Model 8065992745, UDI-DI 00380659927454). The recall involves 26 specific lot numbers.

Alcon has detected an increase in complaint reports related to inadequate sharpness of the surgical knives. The issue affects specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance ophthalmic knife models.

The affected ophthalmic knives were distributed nationwide in the United States and internationally to numerous countries and territories spanning North America, South America, Europe, Asia, Africa, and Oceania.

The recalled product

Product
Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE2.75MM AN Model/Catalog Number: 8065992745 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Manufacturer
Alcon Research LLC
Category
Medical Device — Ophthalmic Surgical Instrument
Hazard
Affected units
145,248

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 (20)

  • Model/Catalog Number: 8065992745
  • UDI-DI: 00380659927454
  • Lot numbers: 15X55P
  • 161A1C
  • 162WXV
  • 162WXW
  • 162WXX
  • 1636Y1
  • 1668MJ
  • 1668MK
  • 167R2Y
  • 168UEV
  • 16DFK6
  • 16DFXL
  • 16DNHY
  • 16EV4J
  • 16EV4K
  • 16F1PT
  • 16FXNX
  • 16FXNY

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 · inadequate sharpness

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