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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOPER VISION, INC. CLARITY ONE DAY CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR

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COOPER VISION, INC. CLARITY ONE DAY CONTACT LENSES LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Inflammation (1932); Pain (1994); Red Eye(s) (2038); Increased Sensitivity (2065)
Event Date 10/24/2019
Event Type  Injury  
Event Description
Pt presented with bilateral ocular pain, photophobia, conjunctival erythema. Wearing daily disposable contact lenses as extended wear lenses, purchased online, without a valid or verified prescription, x several years. Told by online retailer that lenses were approved for extended wear. Bilateral uveitis with significant keratic precipitates. Fda safety report id# (b)(4).
 
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Brand NameCLARITY ONE DAY CONTACT LENSES
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
COOPER VISION, INC.
new york NY 10023
MDR Report Key9245058
MDR Text Key164283305
Report NumberMW5090704
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 10/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2019
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? 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? Yes
Type of Device Usage

Patient Treatment Data
Date Received: 10/25/2019 Patient Sequence Number: 1
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