PMA · Approved
Recalled · Class II · 2013Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Starr Surgical Co. · HQL Intraocular Lens
Approved on Apr 2, 2000 through premarket approval, which rests on the device’s own clinical evidence after a 394-day review. It has been recalled 5 times.
- Decided
- Apr 2, 2000
- Review
- 394 days
- Class
- Class III
- Product code
- HQL
- Recalls
- 5
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P990013 has 38 supplements since 2000: 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 |
|---|---|
| 2000 | 1 |
| 2001 | 1 |
| 2004 | 1 |
| 2007 | 7 |
| 2008 | 10 |
| 2009 | 3 |
| 2010 | 4 |
| 2011 | 2 |
| 2014 | 1 |
| 2017 | 4 |
| 2019 | 2 |
| 2020 | 1 |
| 2021 | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 10, 2013 | Class II | Z-1747-2013 | Material/Component Contamination | STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intraocular lenses due to the potential presence of glass particles in the storage vial. |
| Jun 10, 2013 | Class II | Z-1746-2013 | Material/Component Contamination | STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intraocular lenses due to the potential presence of glass particles in the storage vial. |
| May 20, 2011 | Not classified | Z-2706-2011 | Other | The recall was initiated by Staar Surgical due to an error in the Directions for Use (DFU) for Staar Surgical's Collamer Ultraviolet Absorbing Posterior Chamber Single Piece Foldable Intraocular Lens (Collamer IP IOL), also known as the… |
| Jun 17, 2004 | Not classified | Z-1037-04 | Other | Mislabeled in part. Label set, patient chart labels, and patient ID card serial number did not match the IOL serial number. |
| Feb 9, 2004 | Not classified | Z-0539-04 | Other | Risk of hyperopic refractive changes. |
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/P990013 · printed Nov 6, 2026
Cite this page
510(k) Report. “P990013: Collamer Ultraviolet 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/P990013
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026