Allergan Recalls Implant in EU for Loose Silicone Particle

Allergan recalled its Ozurdex 700 mg intravitreal implant because a single loose silicone particle may become detached from the needle sleeve during administration of the implant and may be delivered into the eye along with the implant.

The defect was discovered during a routine manufacturing inspection. Additional testing by Allergan found two to four percent of defective units, but defect rates as high as 22 percent have been reported. 

Although the root cause of the defect has not yet been determined, Allergan identified a corrective action that eliminates creation of the particle and is implementing the correction before releasing additional stock.