Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1688-2016 — LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery.

U.S. FDA — Device Enforcement · United States · 2016-04-14 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1688-2016
Date of alert
2016-04-14
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Alcon Research, Ltd.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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