510(k) · Cleared
Recalled · 2011Bio-Eye II Orbital Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integrated Orbital Implants, Inc. · HPZ Implant, Eye Sphere
Cleared on Feb 7, 2001 after a 105-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled once.
- Decided
- Feb 7, 2001
- Review
- 105 days
- Class
- Class II
- Product code
- HPZ
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK003338 Bio-Eye II Orbital ImplantIntegrated Orbital Implants, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK053298 Alphasphere Orbital ImplantHydron Pty Limited · 2006
Most influential descendants
Showing 1 of 1 · See all- K053298Alphasphere Orbital ImplantHydron Pty Limited · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003338 | Bio-Eye II Orbital Implant | Integrated Orbital Implants, Inc. | 2001 | — |
| +1 | K053298 | Alphasphere Orbital Implant | Hydron Pty Limited | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HPZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HPZ device
- #1 K212741 Ezyporscore 3.6 · 1 generation · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053298 | Alphasphere Orbital Implant | 2006 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 20, 2011 | Not classified | Z-2624-2011 | Other | The recall was initiated because Integrated Orbital Implants has confirmed certain lots of the Coated Bio-Eye were manufactured without expiration dating visible on the packaging. All unlabeled product is currently beyond its expiration… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K053298 (Hydron Pty Limited, 2006) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HPZ devicesHPZ Implant, Eye Sphere: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HPZ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · HPZ
Too few HPZ 510(k)s in any year since 2007 to give a median.
Recalls per year · HPZ
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HPZ
6in 2011
MAUDE reports naming product code HPZ, 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 | 2 | — | 0 | 5 |
| 2008 | 1 | — | 0 | 7 |
| 2009 | 2 | — | 0 | 5 |
| 2010 | 0 | — | 1 | 3 |
| 2011 | 2 | — | 0 | 6 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K003338 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003338: Bio-Eye II Orbital Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003338
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026