# P880081: UV Absorbing Silicone Posterior Chamber Intraocular Lenses

- Pathway: PMA
- Applicant: Johnson & Johnson Surgical Vision, Inc.
- Decided: Oct 31, 1989 after 358 days
- Product code: HQL (Intraocular Lens)
- Device class: 3
- Regulation: 21 CFR 886.3600
- Recalls of this device: 21 (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 26, 2016 · Class II · Z-2864-2016: Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.
- May 13, 2014 · Class II · Z-2273-2014: Units may be labeled with the incorrect diopter power.
- May 13, 2014 · Class II · Z-2272-2014: Units may be labeled with the incorrect diopter power.
- May 13, 2014 · Class II · Z-2287-2014: Units may be labeled with the incorrect diopter power.
- May 13, 2014 · Class II · Z-2283-2014: Units may be labeled with the incorrect diopter power.
- May 13, 2014 · Class II · Z-2282-2014: Units may be labeled with the incorrect diopter power.
- May 13, 2014 · Class II · Z-2278-2014: Units may be labeled with the incorrect diopter power.
- May 13, 2014 · Class II · Z-2280-2014: Units may be labeled with the incorrect diopter power.
- May 13, 2014 · Class II · Z-2271-2014: Units may be labeled with the incorrect diopter power.
- May 13, 2014 · Class II · Z-2274-2014: Units may be labeled with the incorrect diopter power.
- May 13, 2014 · Class II · Z-2277-2014: Units may be labeled with the incorrect diopter power.
- May 13, 2014 · Class II · Z-2281-2014: Units may be labeled with the incorrect diopter power.
- May 13, 2014 · Class II · Z-2279-2014: Units may be labeled with the incorrect diopter power.
- May 13, 2014 · Class II · Z-2276-2014: Units may be labeled with the incorrect diopter power.
- May 13, 2014 · Class II · Z-2275-2014: Units may be labeled with the incorrect diopter power.
- May 13, 2014 · Class II · Z-2285-2014: Units may be labeled with the incorrect diopter power.
- May 13, 2014 · Class II · Z-2286-2014: Units may be labeled with the incorrect diopter power.
- May 13, 2014 · Class II · Z-2284-2014: Units may be labeled with the incorrect diopter power.
- Jan 28, 2014 · Class II · Z-1123-2014: Certain Silicone TECNIS IOLs may be labeled with the incorrect diopter power.
- Oct 31, 2006 · Not classified · Z-0267-2007: These specific serial numbers of lenses are being recalled because AMO has received reports of post-implantation cloudiness related to some lenses contained in this grouping.
- Jul 2, 2003 · Not classified · Z-1036-03: Post operative complaints of cloudiness in the intraocular lenses.

Source page: https://510kreport.com/device/P880081
Methodology: https://510kreport.com/methodology