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

Lot Number T0127676

Device Problem Insufficient Information (3190)

Patient Problem Eye Infections (4466)

Event Type  Injury  

Event Description

This incident was received from the health care professional as reported by the user and limited information is known.The patient stated that they believed they removed their contact lenses, but after a few days, developed irritation the left eye.Upon visiting a&e (accident and emergency) ophthalmology department, they found a lens in his eye and diagnose him with an eye infection.The infection has since been treated successfully, leaving no permanent harm.Patient alleges he had received a case with two lenses where he unknowingly inserted two lenses into his eye and only removed one, resulting in the remaining lens causing the irritation and infection.His eye care practitioner, optom dir at specsavers, does not believe this to be the case as the patient did not indicate any poor vision or other discomfort while wearing that would indicate having instilled two lenses.As of the date of this report additional information is unknown.This event is being reported with an abundance of caution due to the unknown nature or severity of the incident.Should further information become available, a follow-up report will be submitted as appropriate.

Manufacturer Narrative

No product has been made available for manufacturer analysis.Lot number was provided for the device alleged to be involved in the incident.No issues or nonconformance's were found and no trends were identified.No root cause could be established.The relationship between the coopervision device and the incident is unconfirmed.

• Brand Name: CLARITI 1 DAY TORIC (SOMOFILCON A)
• Type of Device: CLARITI 1 DAY TORIC (SOMOFILCON A)
• Manufacturer (Section D): COOPERVISION CL KFT; gorcsev ivan street 7; building c; gyal, budapest 2360 ; HU 2360
• Manufacturer (Section G): COOPERVISION CL KFT; gorcsev ivan street 7; building c; gyal, budapest 2360 ; HU 2360
• Manufacturer Contact: jose rodriguez ; 209 high point dr; victor, NY 14564 ; 5857569847
• MDR Report Key: 16976707
• MDR Text Key: 315779596
• Report Number: 3009108089-2023-00003
• Device Sequence Number: 1
• Product Code: MVN
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K130331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: T0127676
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male