Rayner Intraocular Lenses Limited recalls C-flex 570C +19.0D Intraocular Lens Product Usage: C-flex IOLs are designed to be surgically implanted into the capsula…

Recall date

August 9, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3282-2018

FDA classification

Class II

Brand / firm

Rayner Intraocular Lenses Limited

Sold / distributed

US in the states of MO

Why it was recalled

Firm become aware of reports of post-operative refractive errors following implantation of lenses.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

C-flex 570C +19.0D Intraocular Lens Product Usage: C-flex IOLs are designed to be surgically implanted into the capsular bag of the human eye as a replacement for the crystalline lens following phacoemulsification