MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-08-22 for INDEPENDENT CORNEAL VIEWING CHAMBER IVC-12 manufactured by Bausch & Lomb.
[3646383]
It was reported that the patient underwent dsek surgery due to pseudophakic bullous keratopathy (pbk) on (b)(6) 2012. The donor cornea (1928-12) had been stored in an ivc-12 viewing chamber. Approximately 4 weeks post-operatively, the patient presented with endophthalmitis. A diagnostic vitrectomy was performed and the vitreous fungal culture was positive for candida glabrata. Oral and intravitreal antifungals were administered. According to the transplant surgeon, the cornea remains clear with precipitates and the patient is without pain.
Patient Sequence No: 1, Text Type: D, B5
[11181794]
The initial reporter has indicated that the event is more likely due to patient-related factors, as the patient had a history of multiple ocular problems. According to the initial reporter, this event was reported to the fda by ocular systems, inc. As mfr report # 3005357288-2013-00001. 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 | 1119279-2013-00268 |
| MDR Report Key | 3313026 |
| Report Source | 05,06 |
| Date Received | 2013-08-22 |
| Date of Report | 2013-07-23 |
| Date of Event | 2013-01-10 |
| Date Mfgr Received | 2013-07-23 |
| Device Manufacturer Date | 2012-10-01 |
| Date Added to Maude | 2013-08-29 |
| 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, SUITE 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 | 2013-08-22 |
| Model Number | IVC-12 |
| Lot Number | U8230 |
| Device Expiration Date | 2013-04-10 |
| 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 | 2013-08-22 |