The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2650-2024·Announced 2024-08-28

Ophthalmic Knives Recalled Due to Complaints About Reduced Sharpness

Alcon is recalling ophthalmic knives for increased complaints of reduced sharpness. These surgical instruments require consistent blade sharpness for surgical precision in eye procedures.

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 with no reported injuries or hospitalizations. It constitutes a risk-of-harm medical device where injury has not yet been reported. Per the severity rubric, recalls with no reported injuries and theoretical hazards are scored at most 3 (High).

Plain-English summary

Alcon Research LLC is recalling specific lot numbers of ophthalmic knives, including ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance models (Model 8065772245, ClearCut Safety Intrepid SB 2.2), following an increase in complaint reports related to reduced sharpness.

Consistent blade sharpness is critical for surgical precision during ophthalmic procedures. Reduced sharpness may compromise surgical control, prolong operative time, and potentially affect surgical outcomes.

Approximately 13,824 units were distributed nationwide in the United States and internationally to 44 other countries. Affected units can be identified by lot numbers: 15P7PW, 15TFMD, 15TFME, 15TFMF, 15W7U4, 15W7U5, 15W7U6, 15W7U7, 15W7U8, 15W993, 169KKN, 169KKP, 169KKR, 169KKT, and 169KRX.

Healthcare facilities using these instruments should verify their inventory against the provided lot numbers and contact Alcon for instructions on device replacement or corrective action.

The recalled product

Product
Product Desc: Product Name: CLEARCUT SAFETY INTREPID SB,2.2 Model/Catalog Number: 8065772245 Software Version: N/A Product Description: Ophthalmic knife Component: N/A
Manufacturer
Alcon Research LLC
Category
Medical Device — Ophthalmic Surgical Instrument
Hazard
Affected units
13,824

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 (17)

  • Model/Catalog Number: 8065772245
  • UDI-DI: 00380657722457
  • Lot numbers: 15P7PW
  • 15TFMD
  • 15TFME
  • 15TFMF
  • 15W7U4
  • 15W7U5
  • 15W7U6
  • 15W7U7
  • 15W7U8
  • 15W993
  • 169KKN
  • 169KKP
  • 169KKR
  • 169KKT
  • 169KRX.

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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