PMA · Approved
ApprovedModels 1S & 1P
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Approved on Mar 31, 1983 through premarket approval, which rests on the device’s own clinical evidence after a 987-day review.
- Decided
- Mar 31, 1983
- Review
- 987 days
- Class
- Class III
- Product code
- HQL
- Recalls
- None
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P800049 has 7 supplements since 1985: 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 |
|---|---|
| 1985 | 2 |
| 1991 | 1 |
| 1992 | 1 |
| 1995 | 2 |
| 1998 | 1 |
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)
No FDA recall names this device.
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/P800049 · printed Nov 5, 2026
Cite this page
510(k) Report. “P800049: Models 1S & 1P.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/P800049
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026