PMA · Approved
Recalled · Class II · 2020Soflex UV-Absorbing Silicone Posterior Chamber Intraocular Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bausch & Lomb, Inc. · HQL Intraocular Lens
Approved on Jan 17, 1992 through premarket approval, which rests on the device’s own clinical evidence after a 121-day review. It has been recalled 2 times.
- Decided
- Jan 17, 1992
- Review
- 121 days
- Class
- Class III
- Product code
- HQL
- Recalls
- 2
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P910056 has 58 supplements since 1994: 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 |
|---|---|
| 1994 | 1 |
| 1995 | 2 |
| 1997 | 1 |
| 1999 | 1 |
| 2003 | 1 |
| 2012 | 4 |
| 2013 | 2 |
| 2014 | 3 |
| 2015 | 3 |
| 2016 | 2 |
| 2017 | 3 |
| 2018 | 6 |
| 2019 | 4 |
| 2020 | 6 |
| 2021 | 2 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 6 |
| 2025 | 3 |
| 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 |
|---|---|---|---|---|
| Jun 9, 2020 | Class II | Z-2552-2020 | Unknown/Undetermined by firm | The toric axis marks were misaligned (from the expected position in relation to the haptics) on an implanted lens. |
| Nov 5, 2018 | Class II | Z-0628-2019 | Process control | Cosmetic imperfections on the surface of some lenses. |
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/P910056 · printed Nov 5, 2026
Cite this page
510(k) Report. “P910056: Soflex UV-Absorbing Silicone Posterior Chamber Intraocular Lens.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/P910056
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026