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

Lot Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Event Description

Incident was reported by the user's mother, she believes her child had an allergic reaction to the contact lenses that resulted in emergency medical treatment.Good faith efforts have been made to obtain further information without success.As of the date of this report, additional information is unknown.This event is being reported in an abundance of caution due to the lack of medical information, unconfirmed diagnosis, and unknown patient resolution.

Manufacturer Narrative

No product has been made available for manufacturer analysis and no lot number provided for manufacturer investigation.Given the lack of available device information, the manufacturer is unable to complete further investigations at this time and no root cause can be established.The relationship between the coopervision device and the event is unconfirmed.Should further information become available, the manufacturer will complete further investigations as appropriate and submit a follow-up report as applicable.

• Brand Name: CLARITI 1 DAY (SOMOFILCON A)
• Type of Device: CLARITI 1 DAY (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 ; 209 high point drive; suite 100; victor, NY 14564 ; 5857569874
• MDR Report Key: 14804267
• MDR Text Key: 295041430
• Report Number: 3009108089-2022-00001
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• 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
• Date Manufacturer Received: 05/27/2022
• 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