MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-12-07 for BIO-EYE HA IMPLANT WITH CONFORMER manufactured by Integrated Orbital Implants.
[15628244]
Pt reported that prosthetic eye feels like it is covered with sticky glue in the morning and that the implant is protruding above the peg "as if the implant is growing out of my socket. " pt discussed condition with dr who suggested that the exposure could be watched as it was slowly growing smaller and might heal on its own. Pt elected to have surgery to close exposure and reduce discharge. Pt reports good results 5 weeks post surgery, that conformer being used and that new artificial eye not yet made.
Patient Sequence No: 1, Text Type: D, B5
[15925303]
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. In this instance, the exposure is reported to have been slowly healing on its own; however, pt elected to have it surgically closed. Discharge is an anticipated complication of orbital implant surgery and in particular motility peg surgery. It is generally treated conservatively with the use of topical anti-inflammatories and antibiotics. There is no anticipated long term degradation expected with the use of motility pegs.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027377-2007-00002 |
| MDR Report Key | 961320 |
| Report Source | 04 |
| Date Received | 2007-12-07 |
| Date of Report | 2007-04-17 |
| Date of Event | 2007-04-16 |
| Date Mfgr Received | 2007-04-17 |
| 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 | 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 | 932863 |
| Manufacturer | INTEGRATED ORBITAL IMPLANTS |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-12-07 |