PMA · Approved
Recalled · Class II · 2026Sensar Soft Acrylic UV-Light Absorbing Posterior Chamber Intraocular Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Surgical Vision, Inc. · HQL Intraocular Lens
Approved on Feb 3, 2000 through premarket approval, which rests on the device’s own clinical evidence after a 490-day review. It has been recalled 13 times.
- Decided
- Feb 3, 2000
- Review
- 490 days
- Class
- Class III
- Product code
- HQL
- Recalls
- 13
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P980040 has 174 supplements since 2001: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2001 | 2 |
| 2002 | 1 |
| 2003 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2007 | 12 |
| 2008 | 7 |
| 2009 | 2 |
| 2010 | 5 |
| 2012 | 4 |
| 2013 | 5 |
| 2014 | 11 |
| 2015 | 8 |
| 2016 | 12 |
| 2017 | 9 |
| 2018 | 10 |
| 2019 | 14 |
| 2020 | 14 |
| 2021 | 17 |
| 2022 | 12 |
| 2023 | 8 |
| 2024 | 3 |
| 2025 | 9 |
| 2026 | 6 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HQL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 19, 2026 | Class II | Z-1634-2026 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | 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 | Process control | Two production orders of these IOLs that contain mislabeled IOLs. |
| Sep 20, 2011 | Not classified | Z-0275-2012 | Employee error | 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 | Employee error | The firm is initiating this voluntary recall because of the possibility that certain Sensar IOLs are labeled with an incorrect diopter power. |
The 5 latest of 13 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All HQL devicesHQL Intraocular Lens: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HQL
42in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HQL
Too few HQL 510(k)s in any year since 2007 to give a median.
Recalls per year · HQL
3in 2018
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · HQL
3,792in 2025
MAUDE reports naming product code HQL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 51 | — | 0 | 3,640 |
| 2008 | 48 | — | 1 | 3,137 |
| 2009 | 33 | — | 2 | 1,868 |
| 2010 | 44 | — | 0 | 2,172 |
| 2011 | 32 | — | 9 | 2,672 |
| 2012 | 38 | — | 1 | 2,802 |
| 2013 | 30 | — | 1 | 2,555 |
| 2014 | 18 | — | 0 | 2,649 |
| 2015 | 27 | — | 2 (1) | 4,673 |
| 2016 | 48 | — | 0 | 2,214 |
| 2017 | 41 | — | 0 | 2,386 |
| 2018 | 39 | — | 3 | 2,501 |
| 2019 | 57 | — | 0 | 3,086 |
| 2020 | 49 | — | 0 | 1,981 |
| 2021 | 53 | — | 0 | 2,925 |
| 2022 | 34 | — | 0 | 3,290 |
| 2023 | 29 | — | 0 | 3,906 |
| 2024 | 35 | — | 0 | 3,110 |
| 2025 | 42 | — | 0 | 3,792 |
| 2026 | 38 | — | 0 | — |
https://510kreport.com/device/P980040 · printed Nov 6, 2026
Cite this page
510(k) Report. “P980040: Sensar Soft Acrylic UV-Light Absorbing Posterior Chamber Intraocular Lens.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P980040
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026