# K003071: Glitter Eyes (Tefilcon) Soft (Hydrophilic) Contact Lens for Daily Wear

- Pathway: 510(k) (Special)
- Applicant: Ciba Vision Corporation
- Decided: Dec 13, 2000 after 72 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Mar 17, 2003 · Not classified · Z-0703-03: The lens may partially 'delaminate' in the area of one of the encapsulated cosmetic prints.

Source page: https://510kreport.com/device/K003071
Methodology: https://510kreport.com/methodology