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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US 1-DAY ACUVUE DEFINE WITH LACREON LENSES, SOFT CONTACT, DAILY WEAR

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JOHNSON & JOHNSON VISION CARE, INC. ¿ US 1-DAY ACUVUE DEFINE WITH LACREON LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number 1DL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Irritation (1941); Uveitis (2122); Discharge (2225); Excessive Tear Production (2235)
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
On (b)(6) 2018 an email was received from a patient (pt) who reported about two months ago both eyes became very irritated and ¿infected¿ while wearing the 1-day acuvue define with lacreon brand contact lenses. Pt reported pt ¿had to 6 weeks off of contacts entirely¿. On 10jul2018 a call was placed to the pt and additional information was provided: pt was diagnosed with uveitis ou 2 months ago ((b)(6) 2018) while wearing the suspect 1-day acuvue define with lacreon brand contact lenses. Pt reported light sensitivity, irritation, tearing, discharge ou and went to an eye care provider (ecp). Pt was advised to discontinue contact lens wear and prescribed a steroid eye drop tid and liquid tears. Pt advised the event resolved and was cleared to return to contact lens wear. The pt was given trial lenses in acuvue oasys brand contact lenses. Pt is interested in finding a daily wear colored lens. Pt reported both eyes are currently fine. At the time of the call the pt didn¿t have the treating ecp contact information for additional information. On 01aug2018 an email was received from the pt with additional information: the pt provided the name of an ecp, but no contact information. The pt reported a possible return visit to the ecp provided. An internet phone search was conducted for the ecp contact telephone number. A call was placed to the ecp¿s office, but it was disconnected. Correct ecp contact information was requested from the pt, but nothing additional has been received. This report is being submitted for the pt¿s od as a worst-case event as the diagnosis and treatment were unable to be verified by the treating ecp. The report for the pt's os will be filed in a separate report. The lot is unknown, and the suspect lens was discarded. If any further relevant information is received, a supplemental report will be filed. Serious reportable event trends are reviewed quarterly in franchise management review meetings.
 
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Brand Name1-DAY ACUVUE DEFINE WITH LACREON
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
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 Key7757462
MDR Text Key116252556
Report Number1057985-2018-00099
Device Sequence Number1
Product Code LPL
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
N18033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 07/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1DL
Device Lot NumberUNK-1DL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/10/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 08/07/2018 Patient Sequence Number: 1
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