FDA-Device2018-10-10Class II

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

Rayner Intraocular Lenses Limited
Hazard

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

Sold states
US in the states of MO
Affected count
49
Manufactured in
The Ridley Innovation Centre, 10 Dominion Way, Worthing, United Kingdom
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3282-2018

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