Home / Recalls / Abbott Medical Optics, Inc. / Z-1539-2013

Z-1539-2013 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
June 19, 2013
Initiation Date
May 28, 2013
Termination Date
November 12, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,882 total all systems

Product Description

STAR S3 ActiveTrack Excimer System (STAR S3) Mfg by AMO Manufacturing USA, LLC 510 cottonwood Drive Milpitas, CA 95035 The STAR Excimer Laser System, a class Ill device, is indicated for laser assisted in situ keratomileusis (LASIK) eye surgery in certain patient populations.

Reason for Recall

Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser.

Distribution Pattern

Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, China, Denmark, Finland, France, Germany, Great Britian, Greece, India, Ireland, Italy, Netherlands, New Zealand, Norway, Poland, Puerto Rico, Singapore, Sweden, Turkey, Japan, Spain, Chile, Argentina, Colombia, Brazil, Taiwan, Mexico, South Korea, Venezuela, Paraquay, South Korea, Russian Federation, Costa Rico, Portugal, Uruquay, Martinique, Israel, Bolivia, Ecuador, Lebanon, Thailand, Saudi Arabia, Egypt, Dominican Republic, United Arab Emirates, Czech Republic, Indonesia, Kuwait, Ukraine, Guatemala, Phillipines, Trinidad, Tobago, Mongolia, Jordan, Malaysia, Hong Kong, Bulgaria, Oman, Kazakhstan, Bulgaria, Peru, Bolivia, Croatia, Romania, Yemen, Vietnam, Uzbekistan, Libyia, Slovakia, Algeria, El Salvador, and Cyprus. .

Code Information

Model 0030-4864 - all serial numbers of STAR Excimer Laser Systems that were manufactured prior to 26-Jul-2011.

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-0046-2014 Class II — STAR Excimer Laser System, Model: STAR S2, Catalog Number: 0030-1479, Product is (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-0048-2014 Class II — STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalog N (September 16, 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)