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www.fdanews.com/articles/9941-alcon-recalls-lensx-laser-with-corneal-flap-capability

Alcon Recalls LenSx Laser With Corneal Flap Capability

May 6, 2016

Swiss devicemaker Alcon is recalling its LenSx Laser with corneal flap capability, following reports of incomplete corneal flap creation.

If an incomplete corneal flap in the side cut is identified, the company warns, lifting the flap may result in corneal tears, irregular stromal bed or corneal epithelial defects.

The company plans to upgrade the software on all LenSx Laser systems used to produce the corneal flaps. Customers will be notified when the upgrade is made available.

The recall only applies to LenSx Laser systems for creating corneal flaps for use in LASIK surgery or other treatments that call for lamellar resection of the cornea.