# K142284: Clear Care Plus Cleaning & Disinfectiong Solution with Hydraglyde

- Pathway: 510(k) (Traditional)
- Applicant: Alcon Laboratories, Inc.
- Decided: Jan 26, 2015 after 161 days
- Product code: LPN (Accessories, Soft Lens Products)
- Device class: 2
- Regulation: 21 CFR 886.5928
- 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: 2 generations back to K003345 (2001). 8 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003345: Aosept Plus Cleaning and Disinfecting Solution, Ciba Vision Corporation (2001) Summary page 4.
- K013512: Aosept Clear Care Cleaning and Disinfecting Solution, Ciba Vision Corporation (2001) Summary page 4.
- K022687: Aosept Clear Care Cleaning and Disinfecting Solution, Ciba Vision Corporation (2002) Summary page 4.
- K023455: Aosept Clear Care Cleaning and Disinfecting Solution, Ciba Vision Corporation (2003) Summary page 4.
- K030522: Aosept Clear Care Cleaning and Disinfecting Solution, Ciba Vision Corporation (2003) Summary page 4.
- K031521: Aosept Clear Care Cleaning and Disinfecting Solution, Ciba Vision Corporation (2003) Summary page 4.
- K020802: Renut Multiplus Mullti-Purpose Solution, Bausch & Lomb, Incorporated (2002) Summary page 5.
- K024289: Boston BL-1000-SIM08 Multi-Action Solution, Bausch & Lomb, Incorporated (2003) Summary page 5.

## Most influential descendants
- K191872: Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution (2020), 1 descendant of its own
- K253795: MeniSept 3% Hydrogen Peroxide Cleaning & Disinfecting Solution (2026), 0 descendants of its own
- K191795: AOCup Lens Case with AODisc (2019), 0 descendants of its own

## Recalls of this device
- May 25, 2022 · Class II · Z-1590-2022: Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

## Indications for use
CLEAR CARE PLUS Cleaning & Disinfecting Solution is indicated for use in simultaneous cleaning, daily protein removal, disinfection, and storing of soft (hydrophilic) contact lenses (including silicone hydrogel lenses) and rigid gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses, as recommended by your eye care professional.

Source page: https://510kreport.com/device/K142284
Methodology: https://510kreport.com/methodology