The Recall Desk
ModerateFDA (Devices)·Z-2365-2019·Announced 2019-09-04

Bausch & Lomb Recalls Laseredge 1.1mm Arrow Knife Due to Dull Edge

Bausch & Lomb is recalling Laseredge 1.1mm Arrow Knives used in ophthalmic surgery because the knife edge may be dull.

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. The hazard is a potential dull edge, which is a functional defect rather than a direct contamination or acute injury risk, fitting the Moderate severity criteria for minor defects or low-risk issues.

Plain-English summary

Bausch & Lomb Inc Irb is recalling the Laseredge 1.1mm Arrow Knife Angled (REF E7592) because the knife edge may be dull. The product is available to surgeons for use in ophthalmic surgical procedures.

The recall involves 384 packs containing 6 blades each, totaling 2,304 individual blades. The affected lot numbers are MAWS530 and MAXA950, with an expiry date of 01-2021. The products were distributed nationwide in the United States.

Surgeons and healthcare facilities should stop using the affected products and contact Bausch & Lomb for instructions on return or replacement.

The recalled product

Product
Laseredge 1.1mm Arrow Knife Angled, REF E7592 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 Numbers: MAWS530 MAXA950 Expiry Dates: 01-2021

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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