# P060011: C-Flex Model 570C Intraocular Lens (Iol)

- Pathway: PMA
- Applicant: Rayner Intraocular Lenses, Ltd.
- Decided: May 3, 2007 after 414 days
- Product code: HQL (Intraocular Lens)
- Device class: 3
- Regulation: 21 CFR 886.3600
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Aug 9, 2018 · Class II · Z-3282-2018: Firm become aware of reports of post-operative refractive errors following implantation of lenses.

Source page: https://510kreport.com/device/P060011
Methodology: https://510kreport.com/methodology