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

Catalog Number 1D4

Device Problem No Apparent Adverse Event (3189)

Patient Problems Corneal Ulcer (1796); Dry Eye(s) (1814); Corneal Infiltrates (2231)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2017, our affiliate in (b)(6) was notified via social media post that a patient (pt) reported experiencing corneal infiltrates while wearing an acuvue contact lens.Pt reported a ¿heavy and sticky¿ feeling in the eye after inserting the contact lens (cl).Pt reported having a ¿white spot¿ in the ¿black eye¿ which was ¿just before developing corneal ulcer.¿ pt reported the ¿white spot¿ was still present.Pt reported presenting to an eye care provider (ecp) who advised "the symptom due to immune compromise by stress, knowing that she was using the cl with compliance." pt also reported having dry eye syndrome.On (b)(6) 2017, the japan affiliate confirmed via social media post that the pt was wearing 1 day acuvue trueye at the time of the event.Pt did not provide contact information; unable to follow up for additional information.Eye affected, event date, product and lot number not available.No additional information has been received.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. ¿ US; 7500 centurion parkway; jacksonville FL
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 6976975
• MDR Text Key: 90236308
• Report Number: 1057985-2017-00120
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/04/2017

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: 1D4
• Device Lot Number: UNK-1D4
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/04/2017
• Initial Date FDA Received: 10/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 22