CLARITI 1 DAY MULTIFOCAL (SOMOFILCON A)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-06-11 for CLARITI 1 DAY MULTIFOCAL (SOMOFILCON A) manufactured by Coopervision Cl Kft.

MAUDE Entry Details

• Report Number: 3009108089-2019-00006
• MDR Report Key: 8687802
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2019-06-11
• Date of Report: 2019-07-11
• Date of Event: 2019-05-07
• Date Mfgr Received: 2019-05-13
• Device Manufacturer Date: 2018-10-23
• Date Added to Maude: 2019-06-11
• 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 MELISSA TORPEY
• Manufacturer Street: 5870 STONERIDGE DRIVE SUITE 1
• Manufacturer City: PLEASANTON CA 94588
• Manufacturer Country: US
• Manufacturer Postal: 94588
• Manufacturer Phone: 5857569874
• Manufacturer G1: COOPERVISION CL KFT
• Manufacturer Street: H-2360 GYAL PROLOGIA ULETI PARK, 3EP
• Manufacturer City: GYAL, 7100
• Manufacturer Country: HU
• Manufacturer Postal Code: 7100
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CLARITI 1 DAY MULTIFOCAL (SOMOFILCON A)
• Generic Name: CLARITI 1 DAY MULTIFOCAL (SOMOFILCON A)
• Product Code: MVN
• Date Received: 2019-06-11
• Lot Number: Y0063050
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COOPERVISION CL KFT
• Manufacturer Address: H-2360 GYAL PROLOGIA ULETI PARK, 3EP GYAL, 7100 HU 7100

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	2019-06-11