# P820086: Cibatint (TM) Tinting Process

- Pathway: PMA
- Applicant: Ciba Vision Care
- Decided: Feb 8, 1984 after 415 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.
97 later devices descend from it; 1 cites it directly.
0 of 98 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
- K970746: SEE3 (Lotrafilcon a) Soft Contact Lens (1997), 96 descendants of its own
- 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

## Recalls of this device
- Apr 30, 2007 · Not classified · Z-0793-2007: Base curve of the lenses do not meet specification.
- Nov 12, 2002 · Not classified · Z-0342-03: Lenses were labeled with the wrong prescription.

Source page: https://510kreport.com/device/P820086
Methodology: https://510kreport.com/methodology