FDAFDA · Food and drugs·Recall number Z-0047-2014
STAR ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number: 0030-2450, 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 keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.
Published October 30, 2013 · Recall initiated: September 16, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Abbott Medical Optics, Inc.
- Distributor
- Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Asia Pacific, Canada, Europe, Africa, Middle East, Japan, and Latin America.
- Lot
- All units of these models: STAR S2 Excimer Laser System; STAR S3 ActiveTrak; STAR S4 with Variable Spot Scanning; and STAR S41R; There are no expiration dates for the STAR Excimer Laser Systems.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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