FDA recall Z-3282-2018

Product

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

Reason for recall

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

Distribution

US in the states of MO

Key facts

Status

Terminated

Initiation date

2018-08-09

Report date

2018-10-10

Termination date

2020-11-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Worthing, United Kingdom

Primary source

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