# P980040: Sensar Soft Acrylic UV-Light Absorbing Posterior Chamber Intraocular Lens

- Pathway: PMA
- Applicant: Johnson & Johnson Surgical Vision, Inc.
- Decided: Feb 3, 2000 after 490 days
- Product code: HQL (Intraocular Lens)
- Device class: 3
- Regulation: 21 CFR 886.3600
- Recalls of this device: 13 (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 19, 2026 · Class II · Z-1634-2026: Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as consistently as expected.
- Aug 26, 2016 · Class II · Z-2863-2016: 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.
- Aug 26, 2016 · Class II · Z-2855-2016: 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.
- Aug 26, 2016 · Class II · Z-2860-2016: 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.
- Aug 26, 2016 · Class II · Z-2857-2016: 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.
- Aug 26, 2016 · Class II · Z-2861-2016: 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.
- Aug 26, 2016 · Class II · Z-2858-2016: 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.
- Aug 26, 2016 · Class II · Z-2862-2016: 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.
- Aug 26, 2016 · Class II · Z-2856-2016: 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.
- Aug 26, 2016 · Class II · Z-2859-2016: 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.
- Dec 20, 2012 · Class II · Z-0929-2013: Two production orders of these IOLs that contain mislabeled IOLs.
- Sep 20, 2011 · Not classified · Z-0275-2012: The firm is initiating this voluntary recall because of the possibility that certain Sensar IOLs are labeled with an incorrect diopter power.
- Sep 20, 2011 · Not classified · Z-0276-2012: The firm is initiating this voluntary recall because of the possibility that certain Sensar IOLs are labeled with an incorrect diopter power.

Source page: https://510kreport.com/device/P980040
Methodology: https://510kreport.com/methodology