# P970034: Modified C-Loop, UV-Absorbing Posterior Chamber Intraocular Lenses

- Pathway: PMA
- Applicant: Aaren Scientific
- Decided: Sep 25, 1998 after 431 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
- Aug 2, 2011 · Not classified · Z-1078-2012: The recall was initiated because Aaren Scientific has confirmed that a specific group of lenses were shipped without a complete expiry date showing on the label.
- Aug 2, 2011 · Not classified · Z-1079-2012: The recall was initiated because Aaren Scientific has confirmed that a specific group of lenses were shipped without a complete expiry date showing on the label.

Source page: https://510kreport.com/device/P970034
Methodology: https://510kreport.com/methodology