# P850079: Hydrasoft (Methafilcon B) Contact Lens

- Pathway: PMA
- Applicant: CooperVision, Inc.
- Decided: Jan 31, 1986 after 93 days
- Product code: LPM (Lenses, Soft Contact, Extended Wear)
- Device class: 3
- Regulation: 21 CFR 886.5925
- Recalls of this device: 3 (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
- Jan 13, 2020 · Class II · Z-1227-2020: Incorrect power of lenses than the expected
- Jul 22, 2003 · Not classified · Z-1091-03: Mislabeled with incorrect sphere power.
- Jun 25, 2003 · Not classified · Z-0978-03: The actual sphere power of the lens is lower than the labeled value.

Source page: https://510kreport.com/device/P850079
Methodology: https://510kreport.com/methodology