MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-08-14 for ORA SYSTEM WITH VERIFEYE MESSAGING 8065998329 manufactured by Alcon Research, Llc - Irvine Technology Center.
Report Number | 2028159-2019-01493 |
MDR Report Key | 8893009 |
Report Source | COMPANY REPRESENTATIVE,HEALTH |
Date Received | 2019-08-14 |
Date of Report | 2019-09-18 |
Date of Event | 2019-07-11 |
Date Mfgr Received | 2019-09-05 |
Device Manufacturer Date | 2015-11-19 |
Date Added to Maude | 2019-08-14 |
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 | MS. CINDY MILAM |
Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
Manufacturer City | FORT WORTH TX 76134 |
Manufacturer Country | US |
Manufacturer Postal | 76134 |
Manufacturer Phone | 8176152231 |
Manufacturer G1 | ALCON RESEARCH, LLC - 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 | ORA SYSTEM WITH VERIFEYE MESSAGING |
Generic Name | ABERROMETER, OPHTHALMIC |
Product Code | NCF |
Date Received | 2019-08-14 |
Model Number | NA |
Catalog Number | 8065998329 |
Lot Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | DA |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER |
Manufacturer Address | 15800 ALTON PARKWAY IRVINE CA 92618 US 92618 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2019-08-14 |