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U.S. Department of Health and Human Services

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

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COOPERVISION, INC. PROCLEAR MULTIFOCAL TORIC (OMAFILCON B) Back to Search Results
Device Problem Microbial Contamination of Device (2303)
Patient Problems Bacterial Infection (1735); Eye Injury (1845); Irritation (1941); Encephalitis (2429)
Event Type  Injury  
Manufacturer Narrative
Analysis cannot be performed. No lenses were returned for evaluation and lot number is unknown. The association between coopervision lenses and the event is unconfirmed.
 
Event Description
It was reported that in (b)(6) of 2016 the patient experienced eye irritation and was hospitalized for a bacterial infection and encephalitis while using the product. The patient has since resumed lens use with the same product. Good faith efforts have been made to obtain additional information without success, additional information is unknown. This event is being reported in an abundance of caution due to incomplete diagnosis, lack of medical information, and unclear resolution.
 
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Brand NamePROCLEAR MULTIFOCAL TORIC (OMAFILCON B)
Type of DevicePROCLEAR MULTIFOCAL 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, CA 94588
5857569874
MDR Report Key7417602
MDR Text Key105110348
Report Number1314956-2018-00001
Device Sequence Number1
Product Code LPL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111966
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 04/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/13/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 04/10/2018 Patient Sequence Number: 1
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