PMA · Approved
ApprovedOphtec Capsular Tension Ring Models 276 and 275 and Stabileyes Models STBL2US and STBL13US
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ophtec BV · MRJ Ring, Endocapsular
Approved on Apr 27, 2004 through premarket approval, which rests on the device’s own clinical evidence after a 315-day review.
- Decided
- Apr 27, 2004
- Review
- 315 days
- Class
- Class III
- Product code
- MRJ
- Recalls
- None
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P030023 has 10 supplements since 2011: 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 |
|---|---|
| 2011 | 1 |
| 2012 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2019 | 2 |
| 2022 | 1 |
| 2024 | 2 |
| 2025 | 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 MRJ? 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 MRJ devicesMRJ Ring, Endocapsular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MRJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MRJ
Too few MRJ 510(k)s in any year since 2007 to give a median.
Recalls per year · MRJ
No recall names MRJ since 2007.
Adverse event reports per year · MRJ
3in 2025
MAUDE reports naming product code MRJ, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 3 | — | 0 | 9 |
| 2024 | 4 | — | 0 | 12 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/P030023 · printed Nov 6, 2026
Cite this page
510(k) Report. “P030023: Ophtec Capsular Tension Ring Models 276 and 275 and Stabileyes Models STBL2US and STBL13US.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P030023
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026