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U.S. Department of Health and Human Services

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

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COOPERVISION, INC. PROCLEAR TORIC XR (OMAFILCON B) Back to Search Results
Lot Number CV5487662
Device Problem Torn Material (3024)
Patient Problems Corneal Abrasion (1789); No Code Available (3191)
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
Patient alleges lenses tearing in the right (od) eye resulting in corneal abrasions on numerous occasions while using this product. Good faith efforts have been made to obtain medical information without success. This event is being reported out of an abundance of caution due the allegations of corneal abrasion, incomplete diagnosis, lack of medical information, and unknown resolution.
 
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Brand NamePROCLEAR TORIC XR (OMAFILCON B)
Type of DevicePROCLEAR TORIC XR (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, CA 94588
5857569874
MDR Report Key6536460
MDR Text Key74160619
Report Number1314956-2017-00006
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 05/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/31/2021
Device Lot NumberCV5487662
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 05/02/2017 Patient Sequence Number: 1
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