Recall Z-1688-2016— Alcon Research, Ltd.

Name: FDA recall Z-1688-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-14

Class II · Terminated

Class II FDA medical device recall by Alcon Research, Ltd., initiated 2016-04-14, terminated 2017-10-20. It names one FDA 510(k) clearance: K120732. Product: LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery.. Reason: 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..

Recalling firm: Alcon Research, Ltd.
Classification: Class II
Status: Terminated
Initiated: 2016-04-14
Terminated: 2017-10-20
Firm location: Fort Worth, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K120732 — LENSSX LASER SYSTEMAlcon Lensx, Inc.·cleared 2012-09-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.