MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,08 report with the FDA on 2014-06-05 for IMPLANTABLE MINIATURE TELESCOPE manufactured by Visioncare Ophthalmic Technologies Ltd..
[4514828]
Rer imp # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11967067]
Another device from the same batch was implanted at a different user facility on (b)(6) 2014 and no adverse events have been reported for this pt. The device history records and sterilization records were reviewed for the batch of the device involved and no deviations were found. Visioncare batches (b)(4) were sterilized in the same sterilization load. Sixteen device from these batches were implanted in pts between (b)(6) 2013 and (b)(6) 2014 and no complaints have been received. Sterilization and device bioburden validation are routinely carried out by visioncare ophthalmic technologies and no deviations have been found. A review of the previous adverse event reported in 2012 showed infection by the same source-(b)(6). This previous event was a result of the pt rubbing their eye as reported by the pt's family. No other adverse events or complaints resulting from infections in the eye have been received by visioncare.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005347768-2014-00001 |
| MDR Report Key | 3909136 |
| Report Source | 07,08 |
| Date Received | 2014-06-05 |
| Date Mfgr Received | 2014-05-14 |
| Device Manufacturer Date | 2012-08-01 |
| Date Added to Maude | 2014-07-03 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | BORIS ARADOVSKY |
| Manufacturer Street | 21 YEGIA KAPAYIM ST. |
| Manufacturer City | PETAH TIKVA 49130 |
| Manufacturer Country | IS |
| Manufacturer Postal | 49130 |
| Manufacturer Phone | 39284002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPLANTABLE MINIATURE TELESCOPE |
| Product Code | NCJ |
| Date Received | 2014-06-05 |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VISIONCARE OPHTHALMIC TECHNOLOGIES LTD. |
| Manufacturer Address | PETAH TIKVA IS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-05 |