MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-03 for EDGEPLUS VALVED ENTRY SYSTEM 8065751657 manufactured by Alcon Research, Ltd. - Irvine Technology Center.
[96394732]
No lot number was identified with this complaint; therefore, lot history and complaint history reviews could not be conducted. No sample has been returned for evaluation; therefore, the condition of the product could not be verified. Due to an observed increased trend for this event, an internal investigation was initiated to determine if corrective and preventative actions were necessary. A root cause for the increased complaint rate was found to be related to a manufacturing post assembly inspection practice. This complaint does not identify a reported lot and no sample was returned for evaluation so it cannot be determined if the complaint can be attributed to the post assembly inspection. The post assembly inspection has been discontinued and an effectiveness check has been established and will be monitored periodically. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[96394734]
A customer reported experiencing ongoing issues with leaking trocars. Patient outcome is unknown. The reporter indicated that no further information was available. No product samples are available for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028159-2018-00016 |
| MDR Report Key | 7159700 |
| Date Received | 2018-01-03 |
| Date of Report | 2018-01-03 |
| Date Mfgr Received | 2017-12-06 |
| Date Added to Maude | 2018-01-03 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | EDGEPLUS VALVED ENTRY SYSTEM |
| Generic Name | CANNULA, TROCAR, OPHTHALMIC |
| Product Code | NGY |
| Date Received | 2018-01-03 |
| Model Number | NA |
| Catalog Number | 8065751657 |
| Lot Number | ASKU |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-01-03 |