# K962185: Hydrasoft (East) and Hydrasoft Toric (East) (Methafilcon B) Daily Wear Soft Hydrophilic Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: CooperVision, Inc.
- Decided: Dec 17, 1996 after 194 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- 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. The FDA summary names its predicate without a number.
- (no number) Hydrasoft®: named in the summary without a submission number
- (no number) Hydrasoft® Toric: named in the summary without a submission number

## Recalls of this device
- Jul 22, 2003 · Not classified · Z-1091-03: Mislabeled with incorrect sphere power.

## Indications for use
The HYDRASOFT (East) lens is intended for use as a dai}y wear lens for the correction of refractivg ametropia (myopic, hyperopic and astigmatism) in aphakic and not-aphakic persons with non-diseased eyes.

Source page: https://510kreport.com/device/K962185
Methodology: https://510kreport.com/methodology