Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: Recalled by Bausch & Lomb Surgical, Inc. Due to Haptics breaking during lens loading and insertion.
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Bausch & Lomb Surgical, Inc. directly.
Affected Products
Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The SofPort/SoFlex IOLs are intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients.
Quantity: 72,773 units; 52,787 units (US) 19,986 units (Foreign)
Why Was This Recalled?
Haptics breaking during lens loading and insertion.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Bausch & Lomb Surgical, Inc.
Bausch & Lomb Surgical, Inc. has 10 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report