MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-06-05 for ALCON MICROSURGICAL INSTRUMENTS, IRRIGATING CYSTITOME 8065426020 manufactured by Alcon Research, Llc - Alcon Precision Device.
Report Number | 2523835-2019-00242 |
MDR Report Key | 8671905 |
Report Source | HEALTH PROFESSIONAL |
Date Received | 2019-06-05 |
Date of Report | 2019-10-17 |
Date of Event | 2019-05-21 |
Date Mfgr Received | 2019-10-11 |
Device Manufacturer Date | 2019-03-05 |
Date Added to Maude | 2019-06-05 |
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 - ALCON PRECISION DEVICE |
Manufacturer Street | 714 COLUMBIA AVENUE |
Manufacturer City | SINKING SPRING PA 19608 |
Manufacturer Country | US |
Manufacturer Postal Code | 19608 |
Single Use | 3 |
Previous Use Code | 3 |
Removal Correction Number | NA |
Event Type | 3 |
Type of Report | 3 |
Brand Name | ALCON MICROSURGICAL INSTRUMENTS, IRRIGATING CYSTITOME |
Generic Name | CYSTOTOME |
Product Code | HNY |
Date Received | 2019-06-05 |
Returned To Mfg | 2019-06-14 |
Model Number | NA |
Catalog Number | 8065426020 |
Lot Number | 285814M |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Age | DA |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | ALCON RESEARCH, LLC - ALCON PRECISION DEVICE |
Manufacturer Address | 714 COLUMBIA AVENUE SINKING SPRING PA 19608 US 19608 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2019-06-05 |