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

Recall Z-0048-2014 — STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalog Number: 0030-4077, Product is manufactured and distributed by AMO Manufacturing USA, LLC, Milpitas, CA The STAR Excimer Laser Systems are indicated for laser assisted in situ keratomileusis (LASIK), photorefractive ker

U.S. FDA — Device Enforcement · United States · 2013-09-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0048-2014
Date of alert: 2013-09-16
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Abbott Medical Optics, Inc.
Product category: device
Product type: Devices

Reported risk: This corrective action will address an identified failure of the lamp and illumination system within the laser unit caused by an unexpected failure of a thyristor component on the AC Power Distribution Printed Circuit Board (PCB).

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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