The Recall Desk
ModerateFDA (Devices)·Z-0869-2018·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 complaints regarding dull blades.

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 a voluntary precautionary action taken due to quality control issues (dull blades) without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Bausch + Lomb Inc Irb is voluntarily recalling LASEREDGE Knives, 2.5 MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7550A, STERILE, Rx Only. The recall covers 1,236,749 knives that were distributed nationwide in the United States. These surgical instruments are intended for ophthalmic surgery and are available to surgeons for use in procedures.

The recall was initiated after the company's complaints database was reviewed, revealing an atypical volume of complaints regarding dull blades for various lots. As a precautionary measure, Bausch + Lomb is recalling all product codes manufactured without electro-polish control and penetration force testing.

No specific illnesses or injuries are reported in the source text. Consumers and healthcare providers should stop using the affected products and contact the manufacturer for further instructions.

The recalled product

Product
LASEREDGE Knives, 2.5 MM SLIT KNIFE ANGLED (6/BOX), REF/PRODUCT CODE E7550A, 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.
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 →

Same manufacturer · Bausch & Lomb Inc Irb

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