# P100016: EC-3 Intraocular Lens (Iol) and EC-3 Precision Aspheric Lens (Pal) Iol

- Pathway: PMA
- Applicant: Carl Zeiss Meditec Production, LLC
- Decided: Oct 19, 2010 after 180 days
- Product code: HQL (Intraocular Lens)
- Device class: 3
- Regulation: 21 CFR 886.3600
- Recalls of this device: 3 (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
- Feb 13, 2015 · Class II · Z-1309-2015: Aaren Scientific is recalling intraocular lenses because the instructions for use (IFU) are not fully compliant with US requirements.
- Aug 2, 2011 · Not classified · Z-1076-2012: 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-1077-2012: 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/P100016
Methodology: https://510kreport.com/methodology