Sensar Foldable IOL with OptiEdge. Model number AR40e 21.5 Diopter. The Sensar Foldable IOLs with OptiEdge Design are ul

FDA device recall Z-0276-2012 · posted 2011-11-23 · Terminated

Recall details

Recalling firm

Abbott Medical Optics Inc (AMO)

Reason for recall

The firm is initiating this voluntary recall because of the possibility that certain Sensar IOLs are labeled with an incorrect diopter power.

Action taken

Abbott Medical Optics, Inc. sent an URGENT FIELD SAFETY NOTICE dated September 21, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to stop using and remove the affected product from their inventory, complete and return the included facsimile form to Abbott Medical Optics and indicate the status of each affected serial number on the form. Customers were asked to return the form even if they have no inventory affected by the recall. For any questions customers were instructed to contact their Abbott Medical Optics Customer Service Representative. For any questions regarding this recall call 714-247-8656.

Root cause

Employee error

Status

Terminated

Product code

HQL

Quantity affected

96

Distribution

Worldwide Distribution including China, India, Indonesia, Korea, Malasyia, Taiwan, Thailand, Austria, Finland, France, Germany, Great Britain, Hungary, Italy, Netherlands, Portugal, and Saudy Arabia

Date initiated

2011-09-20

Date posted

2011-11-23

Date terminated

2014-01-08

Location

Santa Ana, CA