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

MAUDE Adverse Event Report: COOPER VISION MANUFACTURING, LTD. CONTACT LENS AVAIRA VITALITY LENSES, SOFT CONTACT, DAILY WEAR

  • 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
 

COOPER VISION MANUFACTURING, LTD. CONTACT LENS AVAIRA VITALITY LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem Insufficient Information (4580)
Event Date 10/30/2020
Event Type  malfunction  
Event Description
Ordered contact lenses from (b)(6). They sent expired contact lenses. They wont refund. I suspect this isn't the first time they have done this. Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCONTACT LENS AVAIRA VITALITY
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
COOPER VISION MANUFACTURING, LTD.
MDR Report Key10903538
MDR Text Key218552172
Report NumberMW5098093
Device Sequence Number1
Product Code LPL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

-
-