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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRO CLEAR CONTACT LENSES, SELF CONTACT, DAILY WEAR

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PRO CLEAR CONTACT LENSES, SELF CONTACT, DAILY WEAR Back to Search Results
Device Problem Torn Material (3024)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/02/2017
Event Type  malfunction  
Event Description
Pro clear contacts, everyone of the contacts i opened were torn and couldn't use them, a 6 month supply cost me (b)(6).
 
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Brand NamePRO CLEAR CONTACT
Type of DeviceLENSES, SELF CONTACT, DAILY WEAR
MDR Report Key6710335
MDR Text Key80119033
Report NumberMW5070939
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
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

Patient Treatment Data
Date Received: 07/10/2017 Patient Sequence Number: 1
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