MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-14 for EDGEPLUS VALVED ENTRY SYSTEM 8065750882 manufactured by Alcon Research, Ltd. - Irvine Technology Center.
[100276857]
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
[100276858]
An ophthalmologist reported leaking trocars during multiple surgeries. The number of patients and devices involved are unknown. The procedures were completed without changing out the product. The procedures were completed without patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028159-2018-00300 |
| MDR Report Key | 7271600 |
| Date Received | 2018-02-14 |
| Date of Report | 2018-05-02 |
| Date of Event | 2018-01-25 |
| Date Mfgr Received | 2018-04-25 |
| Date Added to Maude | 2018-02-14 |
| 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. BRYAN BLAKE |
| 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 | 0 |
| Brand Name | EDGEPLUS VALVED ENTRY SYSTEM |
| Generic Name | CANNULA, TROCAR, OPHTHALMIC |
| Product Code | NGY |
| Date Received | 2018-02-14 |
| Model Number | NA |
| Catalog Number | 8065750882 |
| Lot Number | ASKU |
| ID Number | NA |
| 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. Other | 2018-02-14 |