# P990080: Ceeon Edge Foldable Ultraviolet Light-Absorbing Posterior Chamber Intraocular Lens, Model 911A

- Pathway: PMA
- Applicant: Johnson & Johnson Surgical Vision, Inc.
- Decided: Apr 5, 2001 after 492 days
- Product code: HQL (Intraocular Lens)
- Device class: 3
- Regulation: 21 CFR 886.3600
- Recalls of this device: 2 (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. PMA decisions do not claim a predicate device.

## Recalls of this device
- Oct 5, 2005 · Not classified · Z-0093-06: A small opening (channel or tunnel) in the seal of the outer Tyvek pouch which contains the lens case, in which the sealed intraocular lens is packaged may not be adequately sealed, therefore the pote
- Oct 5, 2005 · Not classified · Z-0095-06: A small opening (channel or tunnel) in the seal of the outer Tyvek pouch which contains the lens case, in which the sealed intraocular lens is packaged may not be adequately sealed, therefore the pote

Source page: https://510kreport.com/device/P990080
Methodology: https://510kreport.com/methodology