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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERVISION LENS CARE LTD.; UNKNOWN
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COOPERVISION LENS CARE LTD.; UNKNOWN Back to Search Results
Device Problem Microbial Contamination of Device (2303)
Patient Problems Red Eye(s) (2038); Swelling (2091); Fungal Infection (2419)
Event Type  Injury  
Manufacturer Narrative
Analysis cannot be performed.No device returned for evaluation and lot number is unknown.The association between coopervision lenses and the event is unconfirmed.
 
Event Description
The patient was by his contact lens specialist in (b)(6) 2017 with no known findings.Shortly after, date unknown, the patients eye became red and swollen and the patient sought medical treatment.The patient was seen by an ophthalmologist and it appeared there was a fungal infection present in the patient's contact lens cleaning solution which has resulting in a fungal infection of the patient's eye.Good faith efforts have been made to obtain additional information without success, efforts are ongoing, additional information is unknown.This event is being reported in an abundance of caution due to incomplete diagnosis, lack of medical information, and unknown resolution.
 
Manufacturer Narrative
New information received 02 april 2018 with clarification of medical device/product involved in the incident.This product is not sold, distributed, or marketed or approved for sale or distribution in the united states, therefore this event does not meet the minimum criteria of an adverse reportable event in the us.
 
Event Description
New information received 02 april 2018 with clarification of medical device/product involved in the incident.This product is not sold, distributed, or marketed or approved for sale or distribution in the united states, therefore this event does not meet the minimum criteria of an adverse reportable event in the us.
 
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Type of Device
UNKNOWN
Manufacturer (Section D)
COOPERVISION LENS CARE LTD.
mace industrial estate
ashford
kent, TN24 8EP
UK  TN24 8EP
MDR Report Key7345025
MDR Text Key102625547
Report Number9615939-2018-00001
Device Sequence Number1
Product Code LPN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 04/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/02/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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