The Recall Desk
HighFDA (Devices)·Z-2153-2015·Announced 2015-07-29

Bausch & Lomb SofPort Advanced Optics Aspheric Lens Recall for Haptic Breakage

Bausch & Lomb is recalling SofPort Advanced Optics Aspheric Lenses because haptics may break during loading and insertion.

What this means for you

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: The recall is classified as FDA Class II, and the hazard involves a structural failure of a medical device during a surgical procedure, which poses a risk of harm even though specific injuries are not detailed in the source text.

Plain-English summary

Bausch & Lomb Surgical, Inc. is recalling the SofPort Advanced Optics Aspheric Lens. The recall is due to a defect where haptics may break during the process of loading and inserting the lens.

The affected units are identified by produce codes LI61AO and LI61SE. A total of 72,773 units were distributed, with 52,787 units in the United States and 19,986 units in foreign countries. The lenses were distributed nationwide in the US and in various countries including Canada, Brazil, and Germany.

Healthcare providers should stop using the affected lenses and contact Bausch & Lomb for further instructions. Consumers who have had these lenses implanted should consult their eye care professional.

The recalled product

Product
Bausch & Lomb SofPort Advanced Optics Aspheric Lens
Manufacturer
Bausch & Lomb Surgical, Inc.
Category
Medical Device — Intraocular Lens
Hazard

Distribution

Distributed nationwide across the United States.

The notice also names 42 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Bausch & Lomb Surgical, Inc. 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 Surgical, Inc.

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Same hazard · structural failure

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