MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-09-20 for INDEPENDENT CORNEAL VIEWING CHAMBER IVC-12 manufactured by Bausch + Lomb.
[2894228]
It was reported that two pts ((b)(6)) received cornea transplants from the same donor ((b)(6)). Pt (b)(6) developed endophthalmitis. Enterococcus was identified on the donor cornea rim culture. Pt was treated with vancomycin and vitrectomy; however, the infection did not clear and enucleation was performed on (b)(6) 2012. This report is for pt (b)(6) involving the pt's right eye. Please reference mdr #: 1119279-2012-00208 for pt (b)(6). On (b)(4) 2012, additional info was received indicating that the corneas had been stored in ivc-12 corneal viewing chambers. Per the reporter, the ivc-12 corneal viewing chambers appeared to be sealed properly, and were described as looking good. No cultures were taken prior to storing the corneas in optisol gs cornea storage media or ivc-12 corneal viewing chambers. The reporter also indicated that there were no routine cultures performed upon harvesting the corneas from the donor as corneas are non-sterile tissue. The rim culture of cornea (b)(6) was done by the surgeon at the time of transplant per surgeon's routine procedure. The pt's preoperative bcva was counting fingers. Pt's bcva decreased to hand motion as of (b)(6) 2012.
Patient Sequence No: 1, Text Type: D, B5
[10207622]
Investigation results: the lot history record and the sterilization batch record were reviewed for lot number u7933 and no discrepancies or deviations that would contribute to the reported event were noted. All end-product release criteria were met. The sterilization cycle and parameters met the acceptance criteria. Our investigation revealed that the ivc-12 corneal viewing chamber was manufactured within specifications and there is no evidence of any defect in the sterility records. Based on the current info, the specific root cause of the event cannot be determined. This event has been previously reported on manufacturer's report number 1119279-2012-00172 for optisol-gs cornea storage media.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119279-2012-00207 |
| MDR Report Key | 2757432 |
| Report Source | 05,06 |
| Date Received | 2012-09-20 |
| Date of Report | 2012-08-20 |
| Date of Event | 2012-06-28 |
| Date Mfgr Received | 2012-08-20 |
| Device Manufacturer Date | 2012-04-01 |
| Date Added to Maude | 2012-09-26 |
| 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 Street | 3365 TREECOURT INDUSTRIAL BLVD. |
| Manufacturer City | ST. LOUIS MO 63122 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63122 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INDEPENDENT CORNEAL VIEWING CHAMBER |
| Generic Name | INDEPENDENT VIEW CHAMBER |
| Product Code | LYX |
| Date Received | 2012-09-20 |
| Model Number | IVC-12 |
| Lot Number | U7933 |
| Device Expiration Date | 2013-02-28 |
| 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 | ST. LOUIS MO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention; 2. Deathisabilit | 2012-09-20 |