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Sign in to claim this brandINTEGRATED ORBITAL IMPLANTS, INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 11230 Sorrento Valley Rd Ste 135, SAN DIEGO, CA, 92121
- Website
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- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3009688114
- DUNS Number
- —
Catalogue (25)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bio-Eye® | I0018P | FDA UDI | Class II | Active |
| Bio-Eye® | I00024S | FDA UDI | Class II | Active |
| Bio-Eye® | I00018S | FDA UDI | Class II | Active |
| Bio-Eye® | I0022P | FDA UDI | Class II | Active |
| P-K Titanium Motility Peg System | I00049 | FDA UDI | Class II | Active |
| Bio-Eye® | I00016S | FDA UDI | Class II | Active |
| P-K Titanium Motility Peg System | I00087 | FDA UDI | Class II | Active |
| P-K Titanium Motility Peg System | I00051 | FDA UDI | Class II | Active |
| Bio-Eye® | I0018C | FDA UDI | Class II | Active |
| Bio-Eye® | I0020C | FDA UDI | Class II | Active |
| Bio-Eye® | I0024P | FDA UDI | Class II | Active |
| P-K Titanium Motility Peg System | I00045 | FDA UDI | Class II | Active |
| P-K Titanium Motility Peg System | I00057 | FDA UDI | Class I | Active |
| P-K Titanium Motility Peg System | I00100 | FDA UDI | Class II | Active |
| P-K Titanium Motility Peg System | I00089 | FDA UDI | Class II | Active |
| Bio-Eye® | I0022C | FDA UDI | Class II | Active |
| Bio-Eye® | I00020S | FDA UDI | Class II | Active |
| Bio-Eye® | I0016P | FDA UDI | Class II | Active |
| Bio-Eye® | I0020P | FDA UDI | Class II | Active |
| Bio-Eye® | I00022S | FDA UDI | Class II | Active |
| Motility Orbital Implant | K891137 | FDA 510(k) | Class II | Active |
| Bio-Eye Hydroxyapatite Ocular Impland And Conformer | K982562 | FDA 510(k) | Class II | Active |
| Perry-Kolberg (pk) Titanium Motility/Support System | K974203 | FDA 510(k) | Class II | Active |
| Bio-Eye Ii Orbital Implant | K003338 | FDA 510(k) | Class II | Active |
| Perry-Kolberg (pk) Ha-Coated Titanium Sleeve | K000151 | FDA 510(k) | Class II | Active |
Related Companies
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Importers
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Authorities
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FDA Recalls (4)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| May 20, 2011 | Z-2624-2011 | — | terminated | 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 date. |
| Jun 7, 2010 | Z-2292-2010 | — | terminated | 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. |
| Dec 20, 2006 | Z-0396-2007 | — | terminated | The threads on the threaded sleeve were manufactured with left-handed threads, requiring a modification to the surgical technique for proper insertion. Failure to properly identify the affected components and apply the modified insertion technique will result in an inability to insert the sleeve into the implant. |
| Feb 27, 2006 | Z-0012-2007 | — | terminated | 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 product as ''20 mm''. |