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

Catalog Number 1D5

Device Problem No Apparent Adverse Event (3189)

Patient Problems Corneal Ulcer (1796); Irritation (1941); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2018, a patient (pt) from the usa who wore 1-day acuvue trueye contact lenses (cls) emailed to report torn contact lenses (cls).The pt was contacted on 20mar2018 and stated that irritation and discomfort were experienced as well as cls torn, which was noticed upon removal.It was not specified which eye was affected.On (b)(6) 2018, upon contacting the eye care professional (ecp), a representative reported that the pt was being treated for an ulcer (unspecified which eye was affected).The pt canceled the last appointment with the ecp which was scheduled two months prior and the pt¿s contact lens prescription expired in 2015.The ecp office was not able to provide any additional information at that time.Attempts were made to contact the pt and ecp for additional information regarding the ulcer event on 23mar2018, 27mar2018, 30mar2018, 03apr2018, and 10apr2018, but the attempts were unsuccessful.No additional information has been received.It is unknown which eye or lot number is related to the event.It is unknown if any product is available for return.Two lot numbers were received from the pt, but only one lot number was verified.After multiple unsuccessful attempts to reach the pt for verification, the lot number was unable to be verified.It is unknown which lot number was involved in the event or which eye was associated with the event.The lot number provided by the pt expired on 01sep2017.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 1254730620 was produced under normal conditions.If additional information is received, will report within 30 days of receipt.Serious reportable event trends are reviewed quarterly in franchise management review meetings.

• Brand Name: 1-DAY ACUVUE TRUEYE (NARA B)
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ US; 7500 centurion parkway; jacksonville FL
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 7441183
• MDR Text Key: 105843983
• Report Number: 1057985-2018-00067
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2018

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 Catalogue Number: 1D5
• Device Lot Number: UNK-1D5
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/21/2018
• Initial Date FDA Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention