Recall Z-2064-2017— Abbott Medical Optics Inc. (AMO)

Name: FDA recall Z-2064-2017
Creator: U.S. Food and Drug Administration
Published: 2017-04-01

Class II · Terminated

Class II FDA medical device recall by Abbott Medical Optics Inc. (AMO), initiated 2017-04-01, terminated 2017-11-27. FDA's recall record names no specific 510(k) clearance for this event. Product: Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012. Reason: Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process..

Recalling firm: Abbott Medical Optics Inc. (AMO)
Classification: Class II
Status: Terminated
Initiated: 2017-04-01
Terminated: 2017-11-27
Firm location: Santa Ana, CA, United States

Product description

Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012

Reason for recall

Remote possibility that certain solutions in these lots may contain microscopic glass particles due to damage that occurred at the cylinder neck during the manufacturing process.

Data sourced from openFDA. This site is unofficial and independent of the FDA.