MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US 1-DAY ACUVUE MOIST BRAND MULTIFOCAL; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number 1MM

Device Problem No Apparent Adverse Event (3189)

Patient Problems Inflammation (1932); Pain (1994); Red Eye(s) (2038)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2017 a patient in korea reported to our affiliate while using the 1-day moist multifocal brand contact lenses ¿foreign matter¿ was found on the lens and the suspect lens was discarded.Pt reported a visit to the eye care provider (ecp).No additional information was provided.On (b)(6) 2018 after multiple attempts to reach the pt for additional information, the pt returned a call and additional information was obtained: pt reported a ¿white substance in the solution and on the contact lens upon opening the blister¿.The pt attempted to wear the suspect lens and reported pain.Pt reported the eye was red the following morning and went to the ecp.Pt reported ¿inflammation¿ in the eye and the ecp advised no contact lens wear ¿for a while¿.Pt was prescribed seeclean and ofus eye drops to be used five to six times daily.Pt reported he/she tried to use the lenses again and reported the eyes became red on insertion.Pt reported a ¿white foreign matter in the other blisters as well¿.Pt reported the suspect product was discarded and is not available for return.Pt previously wore the acuvue moist brand contact lenses.Pt refused to provide the medical report.On (b)(6) 2018 a call was placed to the pt and additional information was provided: pt reported a follow-up visit to the ecp today and was advised by the that ¿cornea had damage due to the lenses¿.Pt reported the ecp did not prescribe any additional eye drops.No additional medical information was provided.On (b)(6) 2018 a call was placed to the pt and additional information was provided: pt reported the first visit to the ecp was about three weeks ago and is still undergoing treatment.No additional information was provided.No additional medical information has been received.Additional medical information has been requested.The event date is unknown.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 1888360101 was produced under normal conditions.This submission is for the pts os event.The event for the pts od will be filed in a separate report.This event is being reported as a worst-case event as the diagnosis and treatment were not verified with the pts treating ecp.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 MOIST BRAND MULTIFOCAL
• 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: 7242112
• MDR Text Key: 99082242
• Report Number: 1057985-2018-00012
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: KN
• PMA/PMN Number: N18033
• 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: 01/10/2018

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: 05/01/2022
• Device Catalogue Number: 1MM
• Device Lot Number: 1888360101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/10/2018
• Initial Date FDA Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention