MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,02,05,06 report with the FDA on 2003-07-09 for ALPHACOR; ALPHACOR-A, ALPHACOR-P ARTIFICAL CORNEA KPRO II NA manufactured by Argus Biomedical Pty Ltd, Lions Eye Institute Bldg.
[20928003]
In 2003, argus biomedical was advised by a surgeon via email that his patient (implanted with the argus alphacor keratoprosthesis in 2001) had developed a "semi-circular break in the kpro optic from 4. 00 to 11. 00 o'clock". The patient presented with itching and watering of the involved eye. The surgeon was advised that the best course of action was to replace the device, preferably reinforcing the anterior surface with donor tissue. The surgeon explanted the damaged keratoprosthesis and performed replacement surgery. The surgery was reported as being uneventful and no further complications have been reported to date. The patient has had an excellent outcome following the replacement surgery and follow up care will continue to be provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 77002-2003-00001 |
| MDR Report Key | 473605 |
| Report Source | 01,02,05,06 |
| Date Received | 2003-07-09 |
| Date of Report | 2003-07-08 |
| Date of Event | 2003-06-13 |
| Report Date | 2003-06-13 |
| Date Mfgr Received | 2003-06-13 |
| Device Manufacturer Date | 2000-09-01 |
| Date Added to Maude | 2003-07-28 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR CALVIN LONDON |
| Manufacturer Street | 2 VERDYN STREET LIONS EYE INSTITUTE BLDG. |
| Manufacturer City | NEDLANDS WA 6009 |
| Manufacturer Country | AS |
| Manufacturer Postal | WA 6009 |
| Manufacturer Phone | 893810834 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALPHACOR; ALPHACOR-A, ALPHACOR-P ARTIFICAL CORNEA |
| Generic Name | KERATOPROSTHESIS (ARTIFICIAL CORNEA) |
| Product Code | HQM |
| Date Received | 2003-07-09 |
| Returned To Mfg | 2003-06-17 |
| Model Number | KPRO II |
| Catalog Number | NA |
| Lot Number | 160200 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 462454 |
| Manufacturer | ARGUS BIOMEDICAL PTY LTD, LIONS EYE INSTITUTE BLDG |
| Manufacturer Address | 2 VERDUM ST. NEDLANDS WESTERN AUSTRALIA AS 6009 |
| Baseline Brand Name | ALPHACOR; ALPHACOR-A, ALPHACOR-P ARTIFICAL CORNEA |
| Baseline Generic Name | KERATOPROSTHESIS (ARTIFICIAL CORNEA) |
| Baseline Model No | KPRO II |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2003-07-09 |