MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-12-28 for IMPLANTABLE MINIATURE TELESCOPE WA 2.7X PR00020-00 manufactured by Visioncare Ophthalmic Technologies, Ltd.
[63360042]
Device not received by manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[63360043]
The initial imt implant done was on (b)(6) 2016. The surgeon said the imt was in good status at the time of the procedure. During the procedure there was an issue with the iris spilling out of the wound which did make it difficult to implant. Once the imt was implanted he checked and felt that it was stable and secure. In the post-op exams that patient complained of va issues and was not happy with the imt. The surgeon send the patient to be examined by a second physician and the patient was examined on (b)(6) 2016. The second physician noticed the imt was mal-positioned and thought that one haptic was in the bag and that one haptic was out of the bag giving the imt a slightly tilted appearance. He also noticed that there was some vitreous peeking the pupil and that there was some iris coming up to the wound. The patient was complaining of poor vision. He decided to do a re-positioning procedure which took place on (b)(6) 2016. During the procedure the physician noticed that the imt was tilted more than he had initially thought and it was possible that neither haptic was in the bag. As he began to manipulate the leading/posterior haptic he began to suspect that the posterior-capsular bag was compromised (not intact) and it was then that the imt fell back far enough to raise concern about possible retina damage. The patient was sent to have the retina examined. The retina test concluded that the retina looked ok but that the eye was not stable enough to support the imt. The patient was sent for a low vision consultation to assess the benefit of the imt to the patient. The low vision specialist concluded that the patient would not benefit from the imt. The imt explant procedure occurred on (b)(6) 2016. The imt was removed and a cz70 lens was sutured in. The patient was last examined on (b)(6) 2016 and the physician reported that the patient looks good. Vision is the same.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005347768-2016-00003 |
| MDR Report Key | 6208029 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-12-28 |
| Date of Report | 2016-12-28 |
| Date of Event | 2016-11-28 |
| Date Facility Aware | 2016-11-29 |
| Report Date | 2016-11-29 |
| Date Reported to Mfgr | 2016-11-29 |
| Date Mfgr Received | 2016-11-29 |
| Device Manufacturer Date | 2014-12-01 |
| Date Added to Maude | 2016-12-28 |
| 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 | OCCUPATIONAL THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BORIS ARADOVSKY |
| Manufacturer Street | 21 YEGIA KAPAYIM |
| Manufacturer City | PETAH TIKVA, 49130 |
| Manufacturer Country | IS |
| Manufacturer Postal | 49130 |
| Manufacturer Phone | 39284002 |
| Manufacturer G1 | VISIONCARE OPHTHALMIC TECHNOLOGIES, LTD |
| Manufacturer Street | 21 YEGIA KAPAYIM |
| 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 | 2016-12-28 |
| Model Number | WA 2.7X |
| Catalog Number | PR00020-00 |
| Lot Number | 10711 |
| Device Expiration Date | 2017-01-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 15 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VISIONCARE OPHTHALMIC TECHNOLOGIES, LTD |
| Manufacturer Address | YEGIA KAPAYIM 21 PETAH TIKVA, 49130 IS 49130 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-12-28 |