N
Patient 1
DEVICE NOT RECEIVED BY MANUFACTURER.
MAUDE MDR 6208029
- MDR report key
- 6208029
- Report number
- 3005347768-2016-00003
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-11-28
- Date received
- 2016-12-28
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 107
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. BORIS ARADOVSKY
- Address
- 21 YEGIA KAPAYIM PETAH TIKVA, 49130 IS
- Phone
- 392-392-3928
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | IMPLANTABLE MINIATURE TELESCOPE | IMPLANTABLE MINIATURE TELESCOPE | VISIONCARE OPHTHALMIC TECHNOLOGIES, LTD | NCJ | WA 2.7X | PR00020-00 | 10711 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-12-28 | 0 | 1. R |
Event Narratives#
D
Patient 1
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.