MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-06-27 for COATED BIO-EYE HA IMPLANT I0018C manufactured by Integrated Orbital Implants.
[2115339]
Exposure of coated bio-eye. Per the complainant: implantation of ioi implant placed (b)(6) 2008. At postop day #4 ((b)(6) 2008) implant intact, plan to have pt return in 2wks... Lost to fu (pt no-showed) pt returned (b)(6) 2009 (2009) over 1 year later: implant exposed, 3 sutures placed without complication started cipro drops, asked to return in 1 month (b)(6) 2009 implant noted to exposed again, 3 more sutures placed, started on bacitracin ung (b)(6) 2009 4mm exposure noted planned to go to operating room for closure, lost to fu again (b)(6) 2010, pt seen by optometry, noted to have exposure, referred to ophthalmology (our clinic).... Pt did not show, once again lost to f/u (b)(6) 2011 pt again noted to have exposure of implant, we planned to perform surgery, pt showed up for preadmission testing on (b)(6) 2011 (planned surgery on (b)(6) 2011) after testing was performed pt stated he was going to divorce court (b)(6) 2011 and would not be able to be here for his surgery. Currently we are planning on rescheduling surgery for (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[9197136]
Exposure is an anticipated complication of orbital implant surgery. It is generally treated conservatively and is surgically closed in only in the case of large exposure or if the wound does not spontaneously close within a reasonable time period. In this instance the wound required surgical closure. The pt is noted to have been repeatedly nonconformant with physician instructions.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027377-2011-00001 |
| MDR Report Key | 2148883 |
| Report Source | 05 |
| Date Received | 2011-06-27 |
| Date of Report | 2011-06-06 |
| Date of Event | 2009-05-07 |
| Date Mfgr Received | 2011-06-06 |
| Device Manufacturer Date | 2003-12-14 |
| Date Added to Maude | 2011-07-08 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. NATALIE KENNEL, CONSULTANT |
| Manufacturer Street | 11230 SORRENTO VALLEY ROAD SUITE 135 |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8587050350 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COATED BIO-EYE HA IMPLANT |
| Generic Name | IMPLANT, EYE SPHERE, PRODUCT CODE: HPZ |
| Product Code | HPZ |
| Date Received | 2011-06-27 |
| Model Number | I0018C |
| Lot Number | 36307 |
| Device Expiration Date | 2008-12-14 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRATED ORBITAL IMPLANTS |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-06-27 |