Device product
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.
Z-0047-2014
Product summary
- Event
- Event 66304
- Status
- Terminated
- Classification
- Class II
- Quantity
- 834 units in total
- Official record key
device-enforcement:Z-0047-2014
Official wording
Reason: 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).
Code information: 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.
Distribution pattern: Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Asia Pacific, Canada, Europe, Africa, Middle East, Japan, and Latin America.
Derived failure modes
-
Unknown
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).