MAUDE Adverse Event Report: COOPERVISION CL KFT CLARITI 1 DAY MULTIFOCAL (SOMOFILCON A)

Lot Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Corneal Ulcer (1796)

Event Type  Injury  

Manufacturer Narrative

No device sample returned for manufacturer analysis and no lot number reported, no investigation could be completed, and no root cause established.The relationship between the coopervision device and the incident is unconfirmed.

Event Description

It was reported by the eye care practitioner to the manufacturer that a patient experienced a corneal ulcer while using the device.Good faith efforts have been made to obtain further information without success.As of the date of report, additional information is unknown.This event is being reported in an abundance of caution due to unconfirmed diagnosis, lack of medical information, and unknown resolution.

• Brand Name: CLARITI 1 DAY MULTIFOCAL (SOMOFILCON A)
• Type of Device: CLARITI 1 DAY MULTIFOCAL (SOMOFILCON A)
• Manufacturer (Section D): COOPERVISION CL KFT; gorcsev ivan street 7; building c; gyal, 2360 ; HU 2360
• Manufacturer (Section G): COOPERVISION CL KFT; gorcsev ivan street 7; building c; gyal, 2360 ; HU 2360
• Manufacturer Contact: melissa torpey ; 5870 stoneridge drive; suite 1; pleasanton, CA 94588 ; 5857569874
• MDR Report Key: 12102013
• MDR Text Key: 259475444
• Report Number: 3009108089-2021-00004
• Device Sequence Number: 1
• Product Code: MVN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other