# P040045: Vistakon (Senofilcon a) Contact Lens, Clear and Visibility Tinted with UV Blocker

- Pathway: PMA
- Applicant: Vistakon, Division of Johnson & Johnson Vision Car
- Decided: Dec 20, 2005 after 400 days
- Product code: LPM (Lenses, Soft Contact, Extended Wear)
- Device class: 3
- Regulation: 21 CFR 886.5925
- 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
- Oct 19, 2017 · Class II · Z-1209-2018: Some contact lenses were associated with complaints of a foreign matter caught between the blister package and foil.

Source page: https://510kreport.com/device/P040045
Methodology: https://510kreport.com/methodology