• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERVISION MANUFACTURING LTD AVAIRA SPHERE (ENFILCON A)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

COOPERVISION MANUFACTURING LTD AVAIRA SPHERE (ENFILCON A) Back to Search Results
Lot Number 508305002916
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Irritation (1941); Burning Sensation (2146)
Event Type  Injury  
Manufacturer Narrative
Analysis cannot be performed; no lenses were returned for evaluation. The association between coopervision lenses and the event is unconfirmed.
 
Event Description
The patient alleges she experienced eye irritation and a burning sensation in the left (os) eye while using the product. The patient sought medical treatment and was prescribed zylet, a steroid/antibiotic medication. Good faith efforts have been made to obtain additional information without success, additional information is unknown; it is unknown if the medication was prescribed to prevent or preclude permanent impairment of eye function or structure. This event is being reported in an abundance of caution due to incomplete diagnosis, lack of medical information, and unknown resolution.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAVAIRA SPHERE (ENFILCON A)
Type of DeviceAVAIRA SPHERE (ENFILCON 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 Key7413623
MDR Text Key104919549
Report Number9614392-2018-00007
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
PMA/PMN Number
K133627
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 04/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2020
Device Lot Number508305002916
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/13/2018
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 Unkown

Patient Treatment Data
Date Received: 04/10/2018 Patient Sequence Number: 1
-
-