Integrated Orbital Implants Inc
San Diego, CA, US
INTEGRATED ORBITAL IMPLANTS, INC. appears in FDA device records in San Diego, CA. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Integrated Orbital Implants Inc between 1989 and 2001. The busiest year on record is 1998, with 2. The most recent is 2001, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 1 |
| 1998 | 2 |
| 2000 | 1 |
| 2001 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K003338 | BIO-EYE II ORBITAL IMPLANT | HPZ | Substantially Equivalent | |
| K000151 | PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVE | MQU | Substantially Equivalent | |
| K982562 | BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER | HPZ | Substantially Equivalent | |
| K974203 | PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEM | MQU | Substantially Equivalent | |
| K891137 | MOTILITY ORBITAL IMPLANT | HPZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2027377 | 3009688114 | INTEGRATED ORBITAL IMPLANTS, INC. | 11230 Sorrento Valley Rd Ste 135, SAN DIEGO, CA 92121 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2624-2011 | Product Brand Name: Coated Bio-Eye Orbital Implant w/Conformer. Product Generic Name: Implant, Eye Sphere Wrap, Implant, Orbital. Model Number: I0016C, I0018C, I0020C, I0022C, I0024C. Description of the product: The Coated Bio-Eye consists of a coralline hydroxyapatite sphere encased in a resorbable shell that aids in implant insertion and provides a means of securing muscles to the implant. The Coated Bio-Eye Orbital Implant is indicated in orbital implantation following enucleation, or as a secondary orbital implant following extrusion, migration or rotation of primary orbital implants. It is indicated in any situation where materials such as silicone, acrylic, polyethylene or glass orbital implants would be used. | 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. | Terminated | ||
| Z-2292-2010 | Sterile Bio-Eye Hydroxyapatite Orbital Implant and Conformer | 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. | Terminated | ||
| Z-0396-2007 | Perry-Kolberg Titanium Motility/Support System (Threaded Sleeve and Flat Peg), Model Number 100045 The threaded sleeve and flat peg are two components of the P-K Titanium Motility/Support System. The threaded sleeve is an externally threaded cylinder and an internal drilled hole designed to receive a peg. It is placed in the Bioeye Hydroxyapatite Implant with the use of the P-K Titanium threaded sleeve wrench after a hole has been prepared in the implant by drilling with a series of hypodermic needles of gradually increasing sizes. After the threaded sleeve is placed in the implant, any of the P-K Pegs can be inserted. The affected model which is the subject of this recall comes with the flat peg. | 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. | Terminated | ||
| Z-0012-2007 | Bio-Eye Hydroxyapatite (HA) Orbital Implant and Conformer, Model Number: 100020S | 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''. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain