# P010019: Focus Night and Day (Lotrafilcon a) Soft Contact Lenses

- Pathway: PMA
- Applicant: Alcon Laboratories, Inc.
- Decided: Oct 11, 2001 after 204 days
- Product code: LPM (Lenses, Soft Contact, Extended Wear)
- Device class: 3
- Regulation: 21 CFR 886.5925
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
96 later devices descend from it; 1 cites it directly.
0 of 97 devices 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.

## Most influential descendants
- K020139: Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal Design (2002), 95 descendants of its own
- K033919: Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal Designs (2004), 94 descendants of its own
- K052560: Biofinity (Comfilcon a) Soft Contact Lens (2005), 74 descendants of its own
- K100221: INTELLIWAVE3 (2010), 32 descendants of its own
- K073459: Ciba Vision (Lotrafilcon B) Soft Contact Lenses (2008), 17 descendants of its own

## Recalls of this device
- Aug 14, 2018 · Class II · Z-0609-2020: The product may be counterfeit and could have microbial issues.
- Aug 1, 2018 · Class II · Z-1821-2020: Potentially counterfeit products in/and counterfeit packaging were imported to the U.S.

Source page: https://510kreport.com/device/P010019
Methodology: https://510kreport.com/methodology