Device evidence

device-recall:cfres:149193

SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.

Official recall number

Z-2855-2016

Evidence summary

Product code: HQL
Recall status: Terminated
Event initiated: August 26, 2016
Root cause: Process control
Source snapshot: d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product: Z-2855-2016