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Terminated

LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery.

FDA Recall Z-1688-2016 · Posted None

Recalling FirmAlcon Research, Ltd.
Recall StatusTerminated
Product CodeOOE
Date Initiated2016-04-14
Date Terminated2017-10-20
Product Quantity81 units

Reason for Recall

Alcon is conducting a voluntary recall of all LenSx Lasers with Corneal Flap Capability after receiving reports concerning incomplete corneal flap creation, which manifests as an un-dissected area(s) within the side cut.

Firm Action

Recall notification letters were sent to consignees on April 14, 2016. The letter details precautions to be taken by the surgeon and requests the consignee sign and return an acknowledgement form.

Root Cause

Software design (manufacturing process)

Distribution Pattern

United States, Albania, Australia, Brazil, Chile, Costa Rica, Czech Republic, France, Germany, Greece, Hungary, India, Italy, Romania, Slovakia, Spain, Taiwan, Thailand, Turkey, UAE, Ukraine

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K120732LENSSX LASER SYSTEMAlcon Lensx, Inc. · 2012-09-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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