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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPERVISION, INC. PROCLEAR TORIC (OMAFILCON B)

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COOPERVISION, INC. PROCLEAR TORIC (OMAFILCON B) Back to Search Results
Lot Number 10281950012008
Device Problems Difficult to Remove (1528); Torn Material (3024)
Patient Problem Corneal Abrasion (1789)
Event Type  Injury  
Manufacturer Narrative
The association between coopervision lenses and the event is unconfirmed.
 
Event Description
The patient reports that a contact lens tore while in the right (od) eye and could not be removed. The patient alleges she was seen for lens removal and the incident resulted in a corneal abrasion. The patient did not provide further details and did not supply the contact information for the eye care provider. Good faith efforts have been made to obtain additional medical information without success, additional information is unknown. This event is being reported out of an abundance of caution due to the incomplete diagnosis, lack of medical information, and unknown resolution.
 
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Brand NamePROCLEAR TORIC (OMAFILCON B)
Type of DevicePROCLEAR TORIC (OMAFILCON B)
Manufacturer (Section D)
COOPERVISION, INC.
711 north road
scottsville NY 14546
Manufacturer (Section G)
COOPERVISION, INC.
711 north road
scottsville NY 14546
Manufacturer Contact
melissa torpey
5870 stoneridge drive
suite 1
pleasanton 94588
5857569874
MDR Report Key6773151
MDR Text Key82012884
Report Number1314956-2017-00008
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112302
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 08/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2021
Device Lot Number10281950012008
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/02/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/07/2013
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: 08/08/2017 Patient Sequence Number: 1
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