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

STAR S4 with Variable Spot Scanning Excimer System (STAR S4) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations — recall Z-1540-2013

U.S. FDA — Device Enforcement · United States · 2013-05-28 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1540-2013
Date of alert: 2013-05-28
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Abbott Medical Optics, Inc.
Product category: device
Product type: Devices

Reported risk: Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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