MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2016-04-27 for IMPLANTABLE MINIATURE TELESCOPE WA 2.7X PR00020-00 manufactured by Visioncare Ophthalmic Technologies Ltd.
[43780096]
The following report was received from visioncare's senior regional manager who was present and observed the surgery: in regard to the details of the surgery, the rhexis was a bit on the small size. I don't know the exact size because it is difficult to estimate via the monitor but i could certainly see that is was slightly smaller than what i typically see. During the initial attempt to insert the imt,the surgeon encountered some difficulty getting the leading haptic into the bag. He aborted that attempt and puled the imt back out. After brief period of time, he made a second attempt and it was at this time when i recognized that the haptic had broken. The haptic was fully separated and partially extended out of the wound. The imt was removed along with the haptic, the second imt was prepared and eventually was successfully placed in the bag. There was still some difficulty encountered with this second imt because (i assume) of the smaller rhexis. The device was returned to visioncare technologies after explant. The device was inspected under video magnification of 132x and it was seen that there were indications of micro cracks on the base of both of the haptics, the broken haptic and the intact haptic. The other telescope parts were not damaged. A review of the manufacturing records (dhr) for the device did not reveal any non-conformities. The shelf life and transport stability testing carried out included force test, compression force and dynamic fatigue and loop strength testing. Review of the labeling showed that directions for the correct handling of device are provided in the professional use. A device assembled with a carrier from the same batch as the carrier on the explanted device was examined and no signs of micro cracks were seen. Based on the above investigation, it seems that the haptic break was due to excessive compression force being applied to the haptics.
Patient Sequence No: 1, Text Type: N, H10
[43780097]
During the initial attempt to insert the imt, the surgeopn 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 | 3005347768-2016-00002 |
| MDR Report Key | 5611041 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2016-04-27 |
| Date of Report | 2016-04-19 |
| Date of Event | 2016-03-17 |
| Date Mfgr Received | 2016-03-23 |
| Device Manufacturer Date | 2014-12-01 |
| 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 |
| Manufacturer Contact | MR. BORIS ARADOVSKY |
| Manufacturer Street | YEGIA KAPYIM STREET 21 |
| Manufacturer City | PETAH TIKVA, 49130 |
| Manufacturer Country | IS |
| Manufacturer Postal | 49130 |
| Manufacturer Phone | 39284000 |
| Manufacturer G1 | VISIONCARE OPHTAHALMIC TECHNOLOGIES LTD. |
| Manufacturer Street | YEGIA KAPAYIM STREET 21 |
| Manufacturer City | PETAH TIKVA, 49130 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 49130 |
| 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 Eval'ed by Mfgr | Y |
| 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 |