# K020927: Bausch & Lomb Soflens Multifocal (Polymacon) Visibility Tinted Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Bausch & Lomb
- Decided: May 16, 2002 after 56 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K960926 (1996). 2 ancestors in all.
26 later devices descend from it; 4 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960926: Power Plus (Polymacon) Soft (Hydrophilic) Aspheric Contact Lens, Unilens Corp., USA (1996) Summary page 1.
- K962804: Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker, Vistakon, Johnson & Johnson Vision Products, Inc. (1996) Summary page 1.
- (no number) Optima™ FW (polymacon) Visibility Tinted Contact Lens: named in the summary without a submission number

## Most influential descendants
- K050948: Purevision Multi-Focal (Balafilcon a) Visibility Tinted Contact Lens (2005), 13 descendants of its own
- K131208: Bausch + Lomb Procomfort (Samfilcon a) Contact Lens, Bausch + Lomb Procomfort (Samfilcon a) Contact Lens for Presbyopia, (2013), 9 descendants of its own
- K132854: Eye Secret 38 UV Aspheric (Polymacon) Soft (Hydrophilic) Contact Lens for Daily Wear (2013), 6 descendants of its own
- K143052: Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily;Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens (2014), 3 descendants of its own
- K132715: Bausch + Lomb Bioture Oneday for Presbyopia (Nesofilcon a) Contact Lens (2013), 3 descendants of its own

## Indications for use
BAUSCH & LOMB® SofLens™ MulfiFocal (polymacon) Visibility Tinted Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity The lens provides a power range of +20.00 to -20.00 diopters with add power ranging from +1.00D to +5.00D. Replacement schedules may vary from patient to patient, and should be decided by eye care practitioners in consultation with their patients. The lens is to be cleaned, rinsed and disinfected each time it is removed from the patient’s eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lens may be disinfected using a chemical disinfection system.

Source page: https://510kreport.com/device/K020927
Methodology: https://510kreport.com/methodology