MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-07-26 for IDEPENDENT CORNEAL VIEWING CHAMBER IVC-12 manufactured by Bausch & Lomb.
[3610362]
It was reported that the pt underwent dsek surgery for fuch's dystrophy on (b)(6) 2012. The donor cornea ((b)(4)) had ben stored in an ivc-12 viewing chamber. The donor rim was cultured one day after surgery and was positive for "light growth of year. " the recipient presented with an infection; an aqueous humor fungal culture collected on (b)(6) 2013 tested positive on fungus (candida species, not albicans, glabrata, tropicalis or krusei). According to the transplant surgeon, the recipient's condition worsened adn the recipient underwent penetrating keratoplasty (pkp) surgery on (b)(6) 2013, replacing the dsek graft. The recipient continues to be monitored.
Patient Sequence No: 1, Text Type: D, B5
[10983057]
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 | 1119279-2013-00239 |
| MDR Report Key | 3255609 |
| Report Source | 05,06 |
| Date Received | 2013-07-26 |
| Date of Report | 2013-06-27 |
| Date of Event | 2013-01-17 |
| Date Mfgr Received | 2013-06-27 |
| Device Manufacturer Date | 2012-08-01 |
| Date Added to Maude | 2013-08-01 |
| 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 | BAUSCH & LOMB |
| Manufacturer Street | 3365 TREECOURT INDUSTRIAL PARK |
| 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 | IDEPENDENT CORNEAL VIEWING CHAMBER |
| Generic Name | INDEPENDENT VIEW CHAMBER |
| Product Code | LYX |
| Date Received | 2013-07-26 |
| Model Number | IVC-12 |
| Lot Number | U8812 |
| Device Expiration Date | 2013-07-02 |
| 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. Other | 2013-07-26 |