MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-06-05 for IMPLANTABLE MINIATURE TELESCOPE WA 2.7X PR00020-00 manufactured by Visioncare Ophthalmic Technologies, Inc..
[19560097]
On (b)(6) 2014 a pt underwent telescope implantation for end-stage macular degeneration. At the day one postoperative exam, there were no signs of infection. Again at the one-week postoperative visit there was no sign of infection. The pt was diagnosed with an eye infection on (b)(6) 2014. The pt was seen by the surgeon on (b)(6) 2014, and an evisceration of the eye was performed on (b)(6) 2014. A culture was taken to identify the cause of the infection and it has been identified as (b)(6). The source of this infection has not been identified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005251015-2014-00001 |
| MDR Report Key | 4038045 |
| Report Source | 99 |
| Date Received | 2014-06-05 |
| Date of Report | 2012-04-10 |
| Date of Event | 2012-04-09 |
| Date Facility Aware | 2014-05-09 |
| Report Date | 2014-05-06 |
| Date Reported to FDA | 2014-05-06 |
| Date Reported to Mfgr | 2014-05-14 |
| Date Added to Maude | 2014-08-27 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 14395 SARATOGA AVE. SUITE 150 |
| Manufacturer City | SARATOGA CA 95070 |
| Manufacturer Country | US |
| Manufacturer Postal | 95070 |
| Manufacturer G1 | VISIONCARE OPHTHALMIC TECHNOLOGIES, INC. |
| Manufacturer Street | 14395 SARATOGA AVE. SUITE 150 |
| Manufacturer City | SARATOGA CA 95070 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95070 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPLANTABLE MINIATURE TELESCOPE |
| Product Code | NCJ |
| Date Received | 2014-06-05 |
| Model Number | WA 2.7X |
| Catalog Number | PR00020-00 |
| Lot Number | 10637 |
| Device Expiration Date | 2015-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 18 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VISIONCARE OPHTHALMIC TECHNOLOGIES, INC. |
| Manufacturer Address | PETAH TIKVA IS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-06-05 |