MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-12-07 for COATED BIO-EYE HA IMPLANT WITH CONFORMER manufactured by Integrated Orbital Implants.
[783887]
Physician reported that patient received bio-eye 2006. Patient presented with a central exposure post operatively that was successfully closed 2 months post op. Now at 7 months post op the patient has a 4 mm central exposure. It is also noted that the anterior polymer is intact. The physician asks for suggestions regarding repair.
Patient Sequence No: 1, Text Type: D, B5
[7897090]
Exposure is an anticipated complication of orbital implant surgery. It is generally treated conservatively and is surgically closed only in the case of large exposures or if the wound does not spontaneously close within a reasonable time period. The polymer visible through the exposure is anticipated as the expected dissolution time of the polymer is 12-15 months.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027377-2007-00003 |
| MDR Report Key | 961324 |
| Report Source | 05 |
| Date Received | 2007-12-07 |
| Date of Report | 2007-04-19 |
| Date of Event | 2007-02-17 |
| Date Mfgr Received | 2007-04-19 |
| Date Added to Maude | 2007-12-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NATALIE KENNEL, CONSULTANT |
| Manufacturer Phone | 8582594355 |
| Manufacturer G1 | INTEGRATED ORBITAL IMPLANTS |
| Manufacturer Street | 12625 HIGH BLUFF DR |
| Manufacturer City | SAN DIEGO CA 92130 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92130 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COATED BIO-EYE HA IMPLANT WITH CONFORMER |
| Generic Name | IMPLANT, EYE SPHERE |
| Product Code | HPZ |
| Date Received | 2007-12-07 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 932869 |
| Manufacturer | INTEGRATED ORBITAL IMPLANTS |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-12-07 |