# P080011: Biofinity (Comfilcon a)

- Pathway: PMA
- Applicant: CooperVision, Inc.
- Decided: Nov 19, 2008 after 226 days
- Product code: LPM (Lenses, Soft Contact, Extended Wear)
- Device class: 3
- Regulation: 21 CFR 886.5925
- Recalls of this device: 4 (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
- Jun 16, 2025 · Class II · Z-2165-2025: Lens blisters may have an incomplete or leaking seal which may render them unsterile.
- Jun 16, 2025 · Class II · Z-2166-2025: Lens blisters may have an incomplete or leaking seal which may render them unsterile.
- Jan 26, 2023 · Class II · Z-1197-2023: Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity
- Jan 26, 2023 · Class II · Z-1198-2023: Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity

Source page: https://510kreport.com/device/P080011
Methodology: https://510kreport.com/methodology