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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 Inflammation (1932); Keratitis (1944); Pain (1994); Red Eye(s) (2038); Discomfort (2330)
Event Date 11/29/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). (b)(6).
 
Event Description
On (b)(6) 2018, an eye care provider (ecp) from (b)(6) reported that the patient (pt) had inflammation after wearing 1-day acuvue® define¿ with lacreon® brand contact lenses (cl). The pt reported left eye (os) pain and redness while wearing the cl on (b)(6) 2018. The pt¿s os was still red after the suspect cl was removed. The pt visited an ecp who diagnosed keratitis os and was prescribed anti-inflammatory eyedrop once every 2 hours; artificial tear eyedrops to apply whenever the pt feels discomfort; eye ointment once before sleep (unspecified names of medications). The pt was informed by the ecp that this was considered aggressive treatment. The pt reported a follow-up visit ¿after several days. ¿ the pt noted that the os is currently better. On (b)(4) 2018, additional information was received from the pt: the pt reported that the name of the eye drops was "sodium hyaluronate eye drops" and "ofloxacin eye drops" (once every 2 hours). The pt was unable to provide the name of the eye ointment. Pt was willing to send the medical report. On (b)(6) 2018, a prescription receipt was received with the following additional information: prescription: ofloxacin eye ointment, 2 times a day; sodium hyaluronate eye drops, 3 times a day; levofloxacin eye drops, every 2 hours. Multiple attempts were made to the pt to obtain the medical report, but nothing additional 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 2344330103 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 Key8196765
MDR Text Key131483376
Report Number9617710-2018-05073
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
Type of Report Initial
Report Date 12/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1DL
Device Lot Number2344330103
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 Received12/03/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/25/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 12/26/2018 Patient Sequence Number: 1
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