Medical Device Recall: Z-0048-2014

FDA Recalls dataset · Firm: Abbott Medical Optics, Inc. · Status: Terminated

Recall Action Class: N/A Date Initiated: 2013-09-16 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0048-2014.

Recall Res Number
Z-0048-2014
Recalling Firm / Manufacturer
Abbott Medical Optics, Inc.
FEI Number
3006695864
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2013-09-16
Date Posted
2013-10-22
Date Terminated
2014-11-12
Product Code
LZS
Event Number
66304
Product Quantity
834 units in total
Product Description 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 keratectomy (PRK), and phototherapeutic keratectomy (PTK) eye surgery in certain patient populations.
Reason for Recall 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).
Action Details The firm, Abbott Medical Optics, Inc., (AMO), sent an "ADVISORY NOTICE and a COVER LETTER FOR ADVISORY NOTICE" dated September 16, 2013 to all affected customers. The letters identified the product, problem, and actions to be taken by the customers. The customers were instructed to complete and return the Star Notification Acknowledgement form via fax to 1-714-247-4530 within 3 business days or mail to Abbott Medical Optics, 510 Cottonwood Drive, MS 347118, Milpitas, CA 95035, and share this advisory notice with your staff. If you have any questions related to operation of STAR Excimer Laser System or documentation requirements associated with this letter, please call AMO Technical Support at 1-800-511-0911 and you will be directed to an AMO Representative.
Distribution Pattern Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Asia Pacific, Canada, Europe, Africa, Middle East, Japan, and Latin America.
Code Information / Serial Numbers 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.

Related Establishments / Registrations

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