OPTISOL-GS CORNEA STORAGE MEDIA 50006-OPT

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number1119279-2013-00146
MDR Report Key3095361
Report Source05,06
Date Received2013-05-03
Date of Report2013-04-04
Date of Event2013-04-04
Date Mfgr Received2013-04-04
Date Added to Maude2013-05-08
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactSHARON SPENCER, DIR
Manufacturer Street30 ENTERPRISE STE 450
Manufacturer CityALISO VIEJO CA 92656
Manufacturer CountryUS
Manufacturer Postal92656
Manufacturer Phone9493891786
Manufacturer G1ALLIANCE MEDICAL PRODUCTS
Manufacturer Street9342 JERONIMO ROAD
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal Code92618
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameOPTISOL-GS CORNEA STORAGE MEDIA
Generic NameLYX/CORNEA STORAGE MEDIA
Product CodeLYX
Date Received2013-05-03
Model Number50006-OPT
Lot NumberW0006580
Device Expiration Date2014-11-26
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBAUSCH + LOMB
Manufacturer AddressALISO VIEJO CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2013-05-03

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