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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 DEFINE WITH LACREON LENSES, SOFT CONTACT, DAILY WEAR

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JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND 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 Foreign Body Sensation in Eye (1869); Itching Sensation (1943); Keratitis (1944); Discomfort (2330)
Event Date 01/06/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
On (b)(6) 2019, an eye care provider (ecp) from (b)(6) reported that a patient (pt) experienced discomfort after insertion of 1-day acuvue® define¿ with lacreon® brand contact lenses (cl). On (b)(6) 2019, additional information was received from the pt: the pt reported experiencing discomfort in the right eye (od) after a few hours of cl wear on (b)(6) 2019. The pt still felt discomfort od after removal of the cl. The pt visited an ophthalmologist on (b)(6) 2019 and was diagnosed with keratitis. Two eye drops were prescribed: ganciclovir eye drops and levofloxacin hydrochloride eye drops, once every 2 hours. The pt is currently experiencing itchiness and still being able to ¿feel something¿ in the od. The pt was not able to provide a medical report. On (b)(6) 2019, additional information was received from the pt: the pt reported the od was better but still dry. The pt did not return to see the ophthalmologist. The pt is currently still using the same previously prescribed eye drops. No additional information has been received. The suspect cl is not available for return. 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 3332160104 was produced under normal conditions. If any further relevant information is received, a supplemental report will be filed.
 
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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. ¿ IRELAND
one technological park plassey
limerick
EI
Manufacturer Contact
rose harrell
7500 centurion parkway
jacksonville, FL 32256
9044433364
MDR Report Key8294520
MDR Text Key134784845
Report Number9617710-2019-00003
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 foreign,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1DL
Device Lot Number3332160104
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 Received01/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/16/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/31/2019 Patient Sequence Number: 1
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