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

Catalog Number 1DM

Device Problem No Apparent Adverse Event (3189)

Patient Problems Bacterial Infection (1735); Discharge (2225)

Event Date 05/21/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2017 a patient (pt) called our (b)(4) affiliate to report that he/she was diagnosed with a ¿suspected bacterial infection¿ while wearing the 1-day acuvue moist brand contact lenses.The pt wore the suspect lenses while playing golf on (b)(6) 2017.The following day, pt reported heavy discharge which prevented the eye from opening (affected eye was not reported).Pt went to an eye care provider (ecp) on (b)(6) 2017 who prescribed eye drops.The pt reported that eye has not fully returned to normal.The pt reported he/she was currently wearing contact lenses.On 21oct2017 a call was placed to the pt and additional information was obtained: the event date was confirmed as (b)(6) 2017 and both eyes were affected.The pt verified the ecp visit date was (b)(6) 2017 and the ecp diagnosed a suspected bacterial infection.The pt was not instructed to discontinue lens wear or return to the ecp for a follow-up visit.The pt reported he/she was advised to return if the symptoms worsened.The pt was prescribed two bottles of levofloxacin ophthalmic solution tid ou.The pt reported that he/she did not return to the clinic as the ¿symptom was not so severe¿.The pt reported he/she finished using the drops prescribed.Currently the pt applies otc drops (name of the medication was not provided).The pt does not have heavy discharge ou currently and reports there are times that the pt has no discharge ou at all.No additional information was received.The suspect lenses were discarded by the pt.This report is for the pts right eye event.A separate report will be filed for the pts left eye event.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 2936600101 was produced under normal conditions.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
• 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: 7021563
• MDR Text Key: 91771689
• Report Number: 9617710-2017-05051
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/18/2017

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 Expiration Date: 07/01/2021
• Device Catalogue Number: 1DM
• Device Lot Number: 2936600101
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/18/2017
• Initial Date FDA Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2016
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention