MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-27 for IMPLANTABLE MINIATURE TELESCOPE WA 2.7X PR00020-00 manufactured by Visioncare Ophthalmic Technologies Ltd.
[43763032]
Patient Sequence No: 1, Text Type: N, H10
[43763033]
During the initial attempt to insert the imt the surgeon encountered some difficulty getting the leading haptic into the bag. He aborted the attempt and pulled the imt back out. Shortly thereafter he tried again to insert the imt and it became apparent that the haptic was broken. The haptic was fully separated and partially extended out of the wound. The imt together with the haptic was removed. The second (backup) imt was prepared and successfully placed in the bag.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005347768-2016-00001 |
| MDR Report Key | 5610909 |
| Date Received | 2016-04-27 |
| Date of Report | 2016-04-19 |
| Date of Event | 2016-03-17 |
| Date Facility Aware | 2016-03-23 |
| Report Date | 2016-03-23 |
| Date Reported to Mfgr | 2016-03-23 |
| Date Added to Maude | 2016-04-27 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPLANTABLE MINIATURE TELESCOPE |
| Generic Name | IMPLANTABLE MINIATURE TELESCOPE |
| Product Code | NCJ |
| Date Received | 2016-04-27 |
| Returned To Mfg | 2016-04-06 |
| Model Number | WA 2.7X |
| Catalog Number | PR00020-00 |
| Lot Number | 10642 |
| Device Expiration Date | 2017-01-31 |
| Device Availability | R |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VISIONCARE OPHTHALMIC TECHNOLOGIES LTD |
| Manufacturer Address | YEGIA KAPAYIM STREET 21 PETAH TIKVA, 49130 IS 49130 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-04-27 |