The Recall Desk
ModerateFDA (Devices)·Z-0868-2018·Announced 2018-03-14

Bausch + Lomb Recalls LaserEdge Knives Due to Dull Blade Complaints

Bausch + Lomb is voluntarily recalling 1,236,749 LaserEdge Knives intended for ophthalmic surgery due to an atypical volume of dull blade complaints.

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 is described as a voluntary precautionary measure due to quality complaints (dull blades) rather than reported injuries or illnesses, fitting the Moderate severity criteria.

Plain-English summary

Bausch + Lomb Inc Irb is voluntarily recalling 1,236,749 units of LASEREDGE Knives, 2.4 MM SLIT KNIFE ANGLED DOUBLE BEVEL, REF/PRODUCT CODE E7549ADB. These sterile, prescription-only medical devices are intended for use in ophthalmic surgery. The recall covers products manufactured without electro-polish control and penetration force testing.

The recall was initiated after a review of the complaints database revealed an atypical volume of complaints regarding dull blades for various lots. Bausch + Lomb is recalling the affected product codes out of an abundance of precaution.

The affected products were distributed nationwide in the United States. Healthcare providers and patients should stop using the recalled knives and contact Bausch + Lomb for further instructions or replacement.

The recalled product

Product
LASEREDGE Knives, 2.4 MM SLIT KNIFE ANGLED DOUBLE BEVEL, REF/PRODUCT CODE E7549ADB, STERILE, Rx Only Product Usage: The LaserEdge Knives are intended for ophthalmic surgery. There is no therapeutic use and they are available to surgeons for use in procedures.
Manufacturer
Bausch & Lomb Inc Irb
Category
Medical Device — Surgical Instruments
Hazard
Affected units
1,236,749

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)

  • none

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 44 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 44 products in this recall →

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