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

Recall Z-2733-2014 — Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system accessory intended for use in the treatment of ocular pathology. " For the Posterior Segment, the Array" LaserLink" is indicated for use in Retinal Photocoagulation and Panretinal Photocoagulation of Vascular and St

U.S. FDA — Device Enforcement · United States · 2014-08-15 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2733-2014
Date of alert: 2014-08-15
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Lumenis, Inc.
Product category: device
Product type: Devices

Reported risk: Lumenis initiated a field-correction for the Array Laser Link", GA-0006700 (SN XXYYZZ) because the system may project an erroneous pattern display on the retina, which is different than the desired pattern.

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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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