MAUDE Adverse Event Report: JOHNSON AND 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.This event is being submitted as a worst-case event for the pts od as the diagnosis and treatment were unable to be verified with the pts treating ecp.The event for the pts os will be filed in a separate report.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.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.

Manufacturer Narrative

On 09mar2018 during a file review it was noted that the lot # 5447280102 was not included on the initial mdr # 9617710-2018-05022 submission on 28feb2018.It was also noted that the product was not labeled for single use.The product is labeled for single use.

• Brand Name: 1-DAY ACUVUE® TRUEYE® (NARA A)
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON AND JOHNSON VISION CARE, INC - IRELAND; one technological park plassey; limerick ; EI
• MDR Report Key: 7303914
• MDR Text Key: 101238432
• Report Number: 9617710-2018-05022
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• PMA/PMN Number: K073485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 03/09/2018

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
• Supplement Dates Manufacturer Received: 03/09/2018
• Supplement Dates FDA Received: 03/15/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention