Devices

Device Recall SoFlex SE Foldable Intraocular Lens

Model / Serial
Model Number: LI61SE, Lot Number: 4916928.
Product Classification
Ophthalmic Devices
Device Class
3
Implanted device?
Yes
Distribution
Lenses were distributed to one distributor and 35 retailers. Worldwide Distribution -- Distributed to Canada, Taiwan and throughout the United States.
Product Description
Bausch & Lomb SoFlex SE Foldable Intraocular Lens. || UPC 4001404, Rx Only, STERILE. || Manufactured by: || Bausch & Lomb Incorporated, 21 Park Place Boulevard, Clearwater, FL 33759. || Intraocular lens indicated for primary implantation for visual correction in adult patients where the cataractous lens has been removed by phacoemulsification. The lens is intended for placement in the capsular bag.
Manufacturer
Bausch & Lomb Inc
1 Event
- Recall of Device Recall SoFlex SE Foldable Intraocular Lens

Manufacturer

Bausch & Lomb Inc

Manufacturer Address
Bausch & Lomb Inc, 1400 North Goodman Street, Rochester NY 14609-3547
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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