MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-19 for EX-PRESS GLAUCOMA FILTRATION DEVICE P-50 PL 47053 manufactured by Optonol Ltd..
[186537473]
Evaluation summary: investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[186537474]
A materials manager reported that a glaucoma filtration device "malfunctioned; would not come off injector x 3 times. " additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003701944-2020-00009 |
| MDR Report Key | 9853741 |
| Report Source | OTHER |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2019-02-14 |
| Date Added to Maude | 2020-03-19 |
| 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. JONATHAN SCHLECH |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8175514979 |
| Manufacturer G1 | OPTONOL LTD. |
| Manufacturer Street | KIRYAT HATIKSHORET COMMUNICATION CENTER |
| Manufacturer City | NEVE-ILAN 90850 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 90850 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EX-PRESS GLAUCOMA FILTRATION DEVICE |
| Generic Name | IMPLANT, EYE VALVE |
| Product Code | KYF |
| Date Received | 2020-03-19 |
| Model Number | P-50 PL |
| Catalog Number | 47053 |
| Lot Number | 073289 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OPTONOL LTD. |
| Manufacturer Address | KIRYAT HATIKSHORET COMMUNICATION CENTER NEVE-ILAN 90850 IS 90850 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-19 |