MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ IRELAND 1-DAY ACUVUE TRUEYE (NARA A); LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number 1D4

Device Problem No Apparent Adverse Event (3189)

Patient Problems Keratitis (1944); Pain (1994)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

On (b)(6) 2018 a patient (pt) in (b)(6) called to report pain in both eyes while wearing the 1-day trueye brand contact lenses on (b)(6) 2018.The pt went to an eye care provider on (b)(6) 2018 and was diagnosed with keratitis ou.The pt was prescribed levofloxacin every 2 hours.The pt could not provide the medical report, but reported the eyes were getting better.The pt was a new wearer of the 1-day acuvue trueye lenses.On 08feb2018 a call was placed to the pt and additional information was provided: the pt reported the keratitis was not infectious and the eyes are fine.The pt could not provide the ecp contact information.No additional medical information was provided.No additional medial information has been received and no additional medical information is expected.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 5447280102 was produced under normal conditions.The suspect lenses were discarded.This event is being submitted as a worst-case event for the pts os as the diagnosis and treatment were unable to be verified with the pts treating ecp.The event for the pts od will be filed 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.

• Brand Name: 1-DAY ACUVUE TRUEYE (NARA A)
• Type of Device: LENSES, 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 Key: 7303930
• MDR Text Key: 101200850
• Report Number: 9617710-2018-05023
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K073485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2022
• Device Catalogue Number: 1D4
• Device Lot Number: 5447280102
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/02/2018
• Initial Date FDA Received: 02/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention