MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-08-15 for OPTISOL-GS CORNEA STORAGE MEDIA 50006-OPT manufactured by Alliance Medical Products.
[2802755]
It was reported that two pts ((b)(6)) received cornea transplants from the same donor ((b)(6)). Pt (b)(6) had preoperative diagnosis of keratoconus. The pt presented with postoperative acute iritis, dense vitreous debris and membrane formation. Because the donor corneal rim culture was positive for enterococcus, the pt was given vancomycin intravitreal injection as a precautionary treatment. A vitreous sample culture was negative and pt status improved. Additional information has been requested. This report is for pt (b)(6). Please reference mdr#: 1119279-2012-00172 for pt (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[10227290]
Please note that the initial reporter sent report to fda under report #: (b)(4). Investigation of this event is in progress. A supplemental report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119279-2012-00173 |
| MDR Report Key | 2706279 |
| Report Source | 05,06 |
| Date Received | 2012-08-15 |
| Date of Report | 2012-07-16 |
| Date of Event | 2012-06-19 |
| Date Mfgr Received | 2012-07-16 |
| Date Added to Maude | 2012-08-21 |
| 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 | SHARON SPENCER, DIRECTOR |
| Manufacturer Street | 30 ENTERPRISE STE 450 |
| Manufacturer City | ALISO VIEJO CA 92656 |
| Manufacturer Country | US |
| Manufacturer Postal | 92656 |
| Manufacturer Phone | 9493891786 |
| Manufacturer G1 | ALLIANCE MEDICLA PRODUCTS |
| Manufacturer Street | 9342 JERONIMO ROAD |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTISOL-GS CORNEA STORAGE MEDIA |
| Generic Name | CORNEA STORAGE MEDIA |
| Product Code | LYX |
| Date Received | 2012-08-15 |
| Model Number | 50006-OPT |
| Lot Number | W0006177 |
| Device Expiration Date | 2014-01-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLIANCE MEDICAL PRODUCTS |
| Manufacturer Address | IRVINE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-08-15 |