MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-03-27 for EDGEPLUS VALVED ENTRY SYSTEM 8065751657 manufactured by Alcon Research, Ltd. - Irvine Technology Center.
[103545003]
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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[103545004]
A customer reported that the trocars had a smoother surface and two of the three slipped out of the eye during a pars plana vitrectomy procedure. There was a significant decrease in pressure and the patient experienced a choroidal hemorrhage. Draining of the choroidal hemorrhage was performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028159-2018-00613 |
| MDR Report Key | 7373075 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-03-27 |
| Date of Report | 2018-05-18 |
| Date of Event | 2018-03-07 |
| Date Mfgr Received | 2018-04-28 |
| Device Manufacturer Date | 2017-07-13 |
| Date Added to Maude | 2018-03-27 |
| 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 | MS. NADIA BAILEY |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152230 |
| Manufacturer G1 | ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER |
| Manufacturer Street | 15800 ALTON PARKWAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EDGEPLUS VALVED ENTRY SYSTEM |
| Generic Name | CANNULA, TROCAR, OPHTHALMIC |
| Product Code | NGY |
| Date Received | 2018-03-27 |
| Model Number | NA |
| Catalog Number | 8065751657 |
| Lot Number | 17025957X |
| ID Number | 380657516575 |
| Device Expiration Date | 2019-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER |
| Manufacturer Address | 15800 ALTON PARKWAY IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2018-03-27 |