Z-1540-2013 Class II Terminated
FDA device recall Z-1540-2013 was initiated by Abbott Medical Optics, Inc. on May 28, 2013 and is designated Class II. Reason for recall: Under specific conditions, there is an unlikely potential to result in inadvertent laser firing of the laser. The recall status is terminated (terminated November 12, 2014). Affected quantity: 1,882 - total all systems.
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
Reason for Recall
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. .