MAUDE Adverse Event Report: COOPERVISION MANUFACTURING, LTD. CLARITI ELITE (SOMOFILCON A)

Lot Number A0153619

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Itching Sensation (1943); Pain (1994); Burning Sensation (2146)

Event Type  Injury  

Manufacturer Narrative

The association between coopervision lenses and the event is unconfirmed.

Event Description

It was reported that the patient experienced redness and pain in the left (os) eye and sought medical treatment.It is also reported that the patient experienced a lens intolerance with burning and itching of the eye.The patient was prescribed cortisone drops and moisture drops.Good faith efforts have been made to obtain additional medical information without success, additional information is unknown.This event is being reported due to incomplete diagnosis, lack of medical information, and unknown resolution.This event is being reported in (b)(6) and the us and does not meet the minimum criteria of an adverse reportable event in any other country or region where the product is sold.Medical information that is received after the date of this justification will be assessed to determine if the event is determined reportable.

Manufacturer Narrative

Device evaluation completed.

• Brand Name: CLARITI ELITE (SOMOFILCON A)
• Type of Device: CLARITI ELITE (SOMOFILCON A)
• Manufacturer (Section D): COOPERVISION MANUFACTURING, LTD.; south point; hamble unit 2; southampton, hampshire SO31 4RF; UK SO31 4RF
• Manufacturer (Section G): COOPERVISION MANUFACTURING, LTD.; south point; hamble unit 2; southampton, hampshire SO31 4RF; UK SO31 4RF
• Manufacturer Contact: melissa torpey ; 5870 stoneridge drive; suite 1; pleasanton, CA 94588 ; 5857569874
• MDR Report Key: 7142837
• MDR Text Key: 95640941
• Report Number: 9614392-2017-00059
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K130342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2021
• Device Lot Number: A0153619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18 YR