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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND 1-DAY ACUVUE MOIST LENSES, SOFT CONTACT, DAILY WEAR

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JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND 1-DAY ACUVUE MOIST LENSES, SOFT CONTACT, DAILY WEAR Back to Search Results
Catalog Number 1DM
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Keratitis (1944); Pain (1994); Red Eye(s) (2038); Discomfort (2330)
Event Type  Injury  
Event Description
On (b)(6) 2018 an eye care provider (ecp) in (b)(6) reported a patient (pt) had red and swollen eyes while wearing the 1-day acuvue moist brand contact lens. On (b)(6) 2018 a call was placed to the pt and additional information was provided: the pt reported discomfort after wearing the lens ou for a ¿period¿. The symptoms continued after the suspect lenses were removed. The following day the pt presented to the ecp and was diagnosed with keratitis. The pt was prescribed tobramycin-dexamethasone 5-6 times a day until recovery. The pt reported the eyes have not yet recovered. The event date was reported as (b)(6) 2018. On (b)(6) 2018 a call was placed to the pt and additional information was provided: the pt reported the eyes were still red, but not painful. Pt can¿t use this contact lens any longer. On (b)(6) 2018 a call was placed to the pt and additional information was provided: the pt has not been back to the ecp for a follow-up visit, so pt is unsure if the keratitis ou has resolved. Pt reported ou redness but has no eye pain. Pt continues to apply the tobramycin-dexamethasone eye drops ou and follows the recommended dosage. On (b)(6) 2018 a call was placed to the pt and additional information was provided: the pt reported the eyes felt better, but ou redness remains. Pt stated the ecp advised the redness will resolve gradually with rest. The pt continues to apply the tobramycin-dexamethasone eye drops as previously prescribed. The pt has not been back to the ecp for a follow-up visit, but will return to the ecp if the symptoms do not resolve. This report is for the right eye (od) event. A separate report will be filed for the left eye (os) event. The suspect lens was discarded. A lot history review was performed and revealed the following: the batch record did not show any abnormalities in monomer and solution testing. All parameters tested were within specification. All sterilization requirements were successfully completed. Lot 5170830104 was produced under normal conditions. 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 MOIST
Type of DeviceLENSES, SOFT CONTACT, DAILY WEAR
Manufacturer (Section D)
JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND
one technological park plassey
limerick
EI
Manufacturer Contact
rose harrell
7500 centurion parkway
jacksonville, FL 32256
9044433364
MDR Report Key8086740
MDR Text Key127910872
Report Number9617710-2018-05067
Device Sequence Number1
Product Code LPL
Combination Product (y/n)Y
Reporter Country CodeCH
PMA/PMN Number
N18033
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,health profe
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1DM
Device Lot Number5170830104
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 Received10/31/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/20/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 11/19/2018 Patient Sequence Number: 1
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