# K091339: Biomedics (Ocufilcon D) Soft (Hydrophilic) Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: CooperVision, Inc.
- Decided: Jan 5, 2010 after 244 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
Longest line of descent: 4 generations back to K942214 (1994). 9 ancestors in all.
9 later devices descend from it; 3 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)
- K012425: Biomedics UV Multifocal, Ocular Sciences Puerto Rico, Inc. (2001) Summary page 4.
- K020193: Ocular Sciences, Inc. Biomedics UV Asphere (Ocufilcon D) Soft (Hydrophilic) Contact Lens, Cl Mcintosh (2002) Summary page 4.
- P890023: H55 Hydrophilic Contact Lens, The Cooper Companies (1989) Summary page 4.

## Cited in the summary but kept off the family tree
- K973003: ocufilcon D Daily Wear Soft Contact Lenses. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K181232: Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia (2018), 3 descendants of its own
- K182523: Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens (2018), 2 descendants of its own
- K182247: ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) (2018), 2 descendants of its own
- K141280: Ilens (Ocufilcon D) Daily Soft Contact Lens (2014), 1 descendant of its own
- K243953: Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color) (2025), 0 descendants of its own

## Recalls of this device
- Nov 20, 2013 · Class II · Z-0543-2014: Lots were labeled with incorrect expiration dates on secondary package (carton). The primary package (blister) is marked with the correct expiration date.

## Indications for use
Spherical and Aspherical - Biomedics 55 (ocufilcon D.) SPHERE and ASPHERE Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from - 20.000 to +20.000 diopters. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuity. Toric - Biomedics 55 (ocufilcon D) TORIC Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -5.00 diopters. Multifocal - Biomedics 55 (ocufilcon D) MULTIFOCAL lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +19.00 diopters and with add powers from +0.25 to +3.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 0.75 diopters or less that does not interfere with visual acuity. The Biomedics 55 (ocufilcon D) Soft (Hydrophilic) Contact Lenses are indicated for single use daily disposable wear or for planned replacement. As prescribed for single use daily disposable wear, patients are instructed to dispose of the lens at each removal. As prescribed for planned replacement, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting system.

Source page: https://510kreport.com/device/K091339
Methodology: https://510kreport.com/methodology