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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERVISION INC. PROCLEAR TORIC, +0.75-2.25X30 8.4/14.4 UNK LENSES, SELF CONTACT, DAILY WEAR

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COOPERVISION INC. PROCLEAR TORIC, +0.75-2.25X30 8.4/14.4 UNK LENSES, SELF CONTACT, DAILY WEAR Back to Search Results
Lot Number 10336500009503
Device Problem Torn Material (3024)
Patient Problem Failure of Implant (1924)
Event Date 05/18/2018
Event Type  Injury  
Event Description
Two contact lenses tore while on her eye causing her to visit her dr's office to have the pieces removed.
 
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Brand NamePROCLEAR TORIC, +0.75-2.25X30 8.4/14.4 UNK
Type of DeviceLENSES, SELF CONTACT, DAILY WEAR
Manufacturer (Section D)
COOPERVISION INC.
scottsville NY 14546
MDR Report Key7650221
MDR Text Key112867449
Report NumberMW5078145
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 Other Health Care Professional
Type of Report Initial
Report Date 06/27/2018
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received06/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/30/2020
Device Lot Number10336500009503
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/28/2018 Patient Sequence Number: 1
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