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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON AND JOHNSON VISION CARE, INC. ACUVUE 2 LENSES, SOFT CONTACT, DAILY WEAR

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JOHNSON AND JOHNSON VISION CARE, INC. ACUVUE 2 LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problems Keratitis (1944); Neovascularization (1978)
Event Date 02/15/2021
Event Type  Injury  
Event Description
Patient was sold contact lenses by (b)(6) when she did not have a valid prescription. She was sold a brand that was different from and inferior to her previous prescription. She has developed corneal neovascularization and keratitis in both eyes. Fda safety report id # (b)(4).
 
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Brand NameACUVUE 2
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
JOHNSON AND JOHNSON VISION CARE, INC.
MDR Report Key11344405
MDR Text Key232901544
Report NumberMW5099473
Device Sequence Number1
Product Code LPL
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 02/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2021
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/17/2021 Patient Sequence Number: 1
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