MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,08 report with the FDA on 2012-05-07 for IMPLANTABLE MINITURE TELESCOPE WA 2.7X PR00020-00 manufactured by Visioncare Ophthalmic Technologies,ltd..
[16047941]
On (b)(6), 2012, a patient underwent telescope implantation for end-stage macular degeneration. On the day one postoperative exam, the eye was quiet, cornea clear, and intraocular pressure was 27 mmhg. At the one-week postoperative visit ((b)(6), 2012), the patient presented with suspected endophthalmitis in the operative eye. The eye was red/puffy, had a flat anterior chamber, and the iris had prolapsed. At this visit, a core vitrectomy was performed, the anterior chamber was re-established, and the iris prolapse was corrected. A culture was taken to identify the cause of the infection and the patient's medication regimen was adjusted. The retina specialist who conducted the interventions described above reported that the telescope remains in-situ, was well-positioned, and in an intact capsular bag. The retina specialist suspected that the cause of the flat anterior chamber, iris prolapse, and endophthalmitis was attributed to the patient's postoperative eye rubbing. The physician questioned the patient and the patient's family member about eye rubbing. Both verified the patient was rubbing the eye, including lifting the eye shield that was provided for protection after surgery. The patient's family member also indicated they had advised the patient to not rub the eye. The physician stated "the event is not device related. " in a follow-up call on (b)(6), 2012 with the retina specialist, he reported the patient's condition as guarded and stable. The patient has been placed on an appropriate regimen of antibiotics and steroids.
Patient Sequence No: 1, Text Type: D, B5
[16328443]
The surgeon stated that the adverse event is not suspected as device related in origin and is attributed to the patient's noncompliance with postoperative instructions (eye rubbing). The device labeling and patient information labeling clearly cautions against eye rubbing postoperatively and is contraindicated in patients who rub their eyes chronically. Two other implant devices from the same batch were implanted at the same user facility on the same day and no adverse events have been reported for these patients. The device history records and sterilization records were reviewed for the batch of the device involved and no deviations were found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005347768-2012-00001 |
| MDR Report Key | 2577663 |
| Report Source | 07,08 |
| Date Received | 2012-05-07 |
| Date of Report | 2012-04-10 |
| Date of Event | 2012-04-09 |
| Date Mfgr Received | 2012-04-10 |
| Device Manufacturer Date | 2011-02-01 |
| Date Added to Maude | 2012-05-17 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | BORIS ARADOVSKY |
| Manufacturer Street | 21 YEGIA KAPAYIM |
| 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 MINITURE TELESCOPE |
| Product Code | NCJ |
| Date Received | 2012-05-07 |
| Model Number | WA 2.7X |
| Catalog Number | PR00020-00 |
| Lot Number | 10603 |
| Device Expiration Date | 2013-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Required No Informationntervention | 2012-05-07 |