The Recall Desk
ModerateFDA (Devices)·Z-2366-2019·Announced 2019-09-04

Bausch & Lomb Recalls Laseredge Knives Due to Possible Dull Edge

Bausch & Lomb is recalling specific Laseredge Knives used in ophthalmic surgery because they may have dull edges.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a functional defect (dull edge) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Bausch & Lomb Inc Irb is recalling 165 packs of Laseredge Knife 1.5mm X 1.7mm TRAPEZOID ANGLED (REF E7599). The recall involves 990 individual blades from Lot Number MAXZ170 with an expiry date of 01/28/2021.

The recall was initiated because the knife edges may be dull. These products were distributed nationwide in the United States and are available to surgeons for use in ophthalmic surgical procedures.

Consumers and healthcare providers should stop using the affected products and contact Bausch & Lomb for further instructions.

The recalled product

Product
Laseredge Knife 1.5mm X 1.7mm TRAPEZOID ANGLED, REF E7599 Product Usage: Available to surgeons for use in ophthalmic surgical procedures.
Manufacturer
Bausch & Lomb Inc Irb
Category
Medical Device — Surgical Instruments
Hazard

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 (1)

  • Lot Number: MAXZ170 Expiry Date: 01/28/2021

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Bausch & Lomb Inc Irb 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 2 products in this recall →

Related recalls

Same manufacturer · Bausch & Lomb Inc Irb

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