Home / Recalls / Abbott Medical Optics, Inc. / Z-0046-2014

Z-0046-2014 Class II Terminated

Recalled by Abbott Medical Optics, Inc. — Milpitas, CA

Recall Details

Product Type
Devices
Report Date
October 30, 2013
Initiation Date
September 16, 2013
Termination Date
November 12, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
834 units in total

Product Description

STAR Excimer Laser System, Model: STAR S2, Catalog Number: 0030-1479, 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).

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

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.

Other recalls by Abbott Medical Optics, Inc.

  • Z-1515-2015 Class II — OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US), and Cata (February 20, 2015)
  • Z-0048-2014 Class II — STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalog N (September 16, 2013)
  • Z-0047-2014 Class II — STAR ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number: 0030-2450, (September 16, 2013)
  • Z-0049-2014 Class II — STAR Excimer Laser System, Model STAR S4 IR, Catalog Number: 0030-4864, Product (September 16, 2013)
  • Z-1539-2013 Class II — STAR S3 ActiveTrack Excimer System (STAR S3) Mfg by AMO Manufacturing USA, L (May 28, 2013)
  • Z-1541-2013 Class II — STAR S4 IR Excimer System (STAR S4 IR) Mfg by AMO Manufacturing USA, LLC 510 (May 28, 2013)
  • Z-1540-2013 Class II — STAR S4 with Variable Spot Scanning Excimer System (STAR S4) Mfg by AMO Manu (May 28, 2013)
  • Z-1670-2013 Class II — Sovereign¿ Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. Th (May 23, 2013)