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 50006-OPT manufactured by Bausch + Lomb.
[3161914]
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 retransplanted on (b)(6) 2013. The surgeon culture candida from the recipient eye at the time of retransplant. This mdr report is for the first lot of optisol gs used for storage. Please reference mdr#: 1119279-2013-00145 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
[10877117]
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 | 1119279-2013-00146 |
| MDR Report Key | 3095361 |
| 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 | 50006-OPT |
| Lot Number | W0006580 |
| Device Expiration Date | 2014-11-26 |
| 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 |