# P890023: H55 Hydrophilic Contact Lens

- Pathway: PMA
- Applicant: The Cooper Companies
- Decided: Sep 19, 1989 after 169 days
- Product code: LPM (Lenses, Soft Contact, Extended Wear)
- Device class: 3
- 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.
18 later devices descend from it; 6 cite it directly.
0 of 19 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
- K984046: Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contac Lens (1999), 15 descendants of its own
- K982947: Biomedics 55 (Ocufilcon D) UV Blocking Soft (Hydrophilic) Contact Lens (1999), 13 descendants of its own
- K020193: Ocular Sciences, Inc. Biomedics UV Asphere (Ocufilcon D) Soft (Hydrophilic) Contact Lens (2002), 11 descendants of its own
- K012425: Biomedics UV Multifocal (2001), 10 descendants of its own
- K091339: Biomedics (Ocufilcon D) Soft (Hydrophilic) Contact Lens (2010), 9 descendants of its own

## Recalls of this device
- Oct 28, 2014 · Class II · Z-0529-2015: Portions of the lots may contain units with an incorrect lens axis condition.

Source page: https://510kreport.com/device/P890023
Methodology: https://510kreport.com/methodology