MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-05-03 for OPTISOL-GS CORNEA STORAGE MEDIA 500006-OPT manufactured by Bausch + Lomb.
[3162460]
It was reported that a donor cornea ((b)(6)) harvested from a deceased donor on (b)(6) 2013 was stored in optisol gs and ivc-12 viewing chamber. No cultures were taken at the time of harvesting. The cornea was then shipped to another company to be cut for a dsaek procedure. During this process the cornea was removed form the viewing chamber and cut and then placed. In another ivc-12 viewing chamber with optisol gs. On (b)(6) 2013 the cornea was transplanted and a rim culture was performed. The culture of the cornea performed by the transplant surgeon at the time of surgery was positive for candida. On (b)(6) 2013 (approximately 6 weeks after the transplant), the pt was diagnosed with endophthalmitis and was re-transplanted on (b)(6) 2013. The surgeon cultured candida from the recipient eye at the time of re-transplant. This mdr report is for the first lot of optisol gs used for storage. Please reference mdr#: 1119279-2013-00146 for the second lot of optisol gs used for storage. Please reference mdr#: 1119279-2013-00147 for the ivc-12 viewing chambers used for storage.
Patient Sequence No: 1, Text Type: D, B5
[10879454]
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 | 1119279-2013-00145 |
| MDR Report Key | 3095344 |
| Report Source | 05,06 |
| Date Received | 2013-05-03 |
| Date of Report | 2013-04-04 |
| Date of Event | 2013-04-04 |
| Date Mfgr Received | 2013-04-04 |
| Date Added to Maude | 2013-05-08 |
| 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 | SHARON SPENCER, DIR |
| Manufacturer Street | 30 ENTERPRISE STE 450 |
| Manufacturer City | ALISO VIEJO CA 92656 |
| Manufacturer Country | US |
| Manufacturer Postal | 92656 |
| Manufacturer Phone | 9493891786 |
| Manufacturer G1 | ALLIANCE MEDICAL 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 | LYX/CORNEA STORAGE MEDIA |
| Product Code | LYX |
| Date Received | 2013-05-03 |
| Model Number | 500006-OPT |
| Lot Number | W0006504 |
| Device Expiration Date | 2014-10-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | ALISO VIEJO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-05-03 |