MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-01-15 for COATED BIO-EYE HA IMPLANT WITH COMFORMER I0018C manufactured by Integrated Orbital Implants, Inc..
[744291]
Dr. Reported that the patient had bleeding and irritation to her eye perhaps caused by the coated bio-eye implant. Dr. Opened up the eye and found sharp edges of implant poking through conjunctiva. She cleaned the anterior part and "nipped away" about 20-30% of implant. She took a culture and closed the conjunctiva.
Patient Sequence No: 1, Text Type: D, B5
[8093776]
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 anterior shell of the coated bio-eye implant is designed to resorb in 12-18 months. Less than 15 months had passed since implantation. Dissolution rates of bioresorbable polymers is dependent upon a number of characteristics including temperatures and hydration, and is anticipated to vary based upon the individual patient's physiology. In the event that the exposure was of prolonged duration the polymer would not be hydrated and therefore not subject to the designed rate of degradation. Dr. Returned samples of the pieces of coating she removed. These were evaluated as follows: the evaluation consisted of visual and photographic evaluation as well as thickness measurements. To date we have no viable hypothesis as to the genesis of the distinctive shapes of the fragments. The fragments provided may have been cut into their characteristics shapes by the action of the physician in removing the exposed polymer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027377-2007-00010 |
| MDR Report Key | 979896 |
| Report Source | 05 |
| Date Received | 2008-01-15 |
| Date of Report | 2007-12-18 |
| Date of Event | 2007-12-18 |
| Date Mfgr Received | 2007-12-18 |
| Device Manufacturer Date | 2004-01-07 |
| Date Added to Maude | 2008-01-22 |
| 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 |
| Manufacturer Phone | 8582594355 |
| Manufacturer G1 | INTEGRATED ORBITAL IMPLANTS, INC. |
| Manufacturer Street | 12625 HIGH BLUFF DR., #314 |
| 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 COMFORMER |
| Generic Name | IMPLANT, EYE SPHERE |
| Product Code | HPZ |
| Date Received | 2008-01-15 |
| Returned To Mfg | 2007-12-21 |
| Model Number | I0018C |
| Catalog Number | I0018C |
| Lot Number | 36307 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 949048 |
| Manufacturer | INTEGRATED ORBITAL IMPLANTS, INC. |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-01-15 |