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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US UNK-SOFT CONTACT LENSES

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JOHNSON & JOHNSON VISION CARE, INC. ¿ US UNK-SOFT CONTACT LENSES Back to Search Results
Catalog Number UNK-SOFT CONTACT LENSES
Device Problem No Apparent Adverse Event (3189)
Patient Problems Corneal Ulcer (1796); Unspecified Infection (1930); Neovascularization (1978); Pain (1994); Loss of Vision (2139)
Event Date 02/20/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
On (b)(6) 2018 during a routine maude database search a health care professional reported that a ¿patient (pt) had been buying ¿colored contacts¿ without a prescription and sleeping in them for years. The pt came to my office with pain in the eyes. The pt had massive amounts of neovascularization in both corneas completely covering the pts central vision. The pt also had a beginning ulcer. The pts immediate infection was treated, but the pt was lost to f/u. The pt will most likely have resulting vision loss and will never be able to wear contacts again due to the damage. ¿ no contact information was provided. No additional information is expected. The event date is reported as (b)(6) 2018. The med watch report number is: mw5075734 it is unknown which eye had the ¿beginning ulcer¿. It was not reported which acuvue brand contact lens the pt was wearing at the time of the event. No lot number was provided and it is unknown if the suspect product is available. This report is for the pt's od event. The pt's os event will be submitted in a separate report. If additional information is received it will be reported within 30 days of receipt. Serious reportable event trends are reviewed quarterly in franchise management review meetings.
 
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Brand NameUNK-SOFT CONTACT LENSES
Type of DeviceUNK-SOFT CONTACT LENSES
Manufacturer (Section D)
JOHNSON & JOHNSON VISION CARE, INC. ¿ US
7500 centurion parkway
jacksonville FL
Manufacturer Contact
rose harrell
7500 centurion parkway
jacksonville, FL 32256
9044433364
MDR Report Key7481396
MDR Text Key107188731
Report Number1057985-2018-00069
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 Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 04/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK-SOFT CONTACT LENSES
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/09/2018
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?
Type of Device Usage

Patient Treatment Data
Date Received: 05/02/2018 Patient Sequence Number: 1
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