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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
Distribution
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.
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