510(k) · Cleared
Recalled · 2010Bio-Eye Hydroxyapatite Ocular Impland and Conformer
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 Dec 28, 1998 as substantially equivalent to K891137 (Integrated Orbital Implants, Inc., 1989) and 2 other predicates after a 158-day review. Its family tree reaches back 1 generation to 1986. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Dec 28, 1998
- Review
- 158 days
- Class
- Class II
- Product code
- HPZ
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 1 generation to K860983 (1986). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K021643HA Orbital ImplantLaboratoire Villanova · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K860983 | Interpore 200 Porous Hydroxyapatite | Interpore Intl. | 1986 | — |
| 0 (this device) | K982562 | Bio-Eye Hydroxyapatite Ocular Impland and Conformer | Integrated Orbital Implants, Inc. | 1998 | — |
| +1 | K021643 | HA Orbital Implant | Laboratoire Villanova | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K891137 | Motility Orbital ImplantSummary page 1…Conformer CLASSIFICATION NAME: Eye sphere implant, 21 CFR 886.3320, Class Il Ophthalmic conformer, 21 CFR 886.3130, Class |l PREDICATE DEVICE: Motility Orbital Implant K891137 Ophthalmic Conformer K945110 (510(k) exempt Federal Register 1-21-98) Interpore 200 Porous Hydroxyapatite K860983. DESCRIPTION… | 1989 |
| * | K945110 | Kolberg Ophthalmic ConformerSummary page 1…E: Eye sphere implant, 21 CFR 886.3320, Class Il Ophthalmic conformer, 21 CFR 886.3130, Class |l PREDICATE DEVICE: Motility Orbital Implant K891137 Ophthalmic Conformer K945110 (510(k) exempt Federal Register 1-21-98) Interpore 200 Porous Hydroxyapatite K860983. DESCRIPTION OF DEVICE: Both the Motility… | 1995 |
| * | K860983 | Interpore 200 Porous HydroxyapatiteSummary page 1…Class |l PREDICATE DEVICE: Motility Orbital Implant K891137 Ophthalmic Conformer K945110 (510(k) exempt Federal Register 1-21-98) Interpore 200 Porous Hydroxyapatite K860983. DESCRIPTION OF DEVICE: Both the Motility Orbital Implant and the Bio-eye Hydroxyapatite Ocular Implant are eye sphere implants… | 1986 |
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 |
|---|---|---|---|
| K021643 | HA Orbital Implant | 2002 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 7, 2010 | Not classified | Z-2292-2010 | Error in labeling | Integrated Orbital Implants, Inc. has initiated a recall of it's Sterile Bio-Eye Hydroxyapatite Orbital Implant and Conformer due to a labeling issue in which the expiration date of the product was omitted. |
| Feb 27, 2006 | Not classified | Z-0012-2007 | Other | The end label on the outer box was mislabeled on 9 of a 10 unit lot. The end label says ''22 mm'' and the implants are actually ''20 mm''. The main label on the cardboard box applied by the contract packager is correct in identifying the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 3 ancestors has a recall.
- Of its descendants, K021643 (Laboratoire Villanova, 2002) 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 | — |
What is it indicated for?
The Bio-eye Hydroxyapatite Ocular Implant is indicated as a primary implant in cases of enucleation and evisceration, and as a secondary implant in cases of poor performance of a primary implant, such as in cases of poor motility, migration, extrusion, chronic infection, enophthalmos, and lid sag. The device is indicated in any situation where silicone, acrylic, polyethylene, glass, or other traditional ocular implants are used.
The Conformer is indicated in all cases in which an orbital implant is used.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982562 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982562: Bio-Eye Hydroxyapatite Ocular Impland and Conformer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982562
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026