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

Catalog Number 1DD

Device Problem No Apparent Adverse Event (3189)

Patient Problems Keratitis (1944); Pain (1994); Red Eye(s) (2038); Swelling (2091); Discharge (2225); Discomfort (2330)

Event Date 07/07/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2017, our affiliate in (b)(6) received a call from a patient (pt) who reported experiencing eye pain and ocular discomfort, eye redness, and both eyes were swollen while wearing 1 day acuvue define contact lenses.Pt reported both eyes remained red and uncomfortable after removing the lenses.Pt reported presenting to a hospital and was advised it was a side effect of wearing contact lenses.Pt reported being prescribed antibiotics and eye drops opti v and optipuro to be taken 3 times a day.Pt reported yellow discharge from both eyes the next day.Pt reported the event occurred on (b)(6) 2017.On (b)(6) 2017, a call was placed to the pt who reported continuing discomfort and ¿a lot of discharge.¿ pt reported that he/she will present again to a doctor for treatment.Pt reported the product in question was discarded.On (b)(6) 2017, pt sent an email providing copies of medical receipts and medical report and a translation was requested from our affiliate in south korea.On (b)(6) 2017, a translation of the medical report was received providing the following information: diagnosis: ¿idiopathic keratitis¿.Date of diagnosis (b)(6) 2017.¿due to above diagnosis, this patient has been treated from (b)(6) as an out patient.Also, the patient has claimed that this event occurred from contact lens wear and it is resolved totally today.¿ ¿this condition is limited for ophthalmologic condition only and any future change requires a new diagnosis" the product in question was discarded.Additional medical information has not been received.Additional information is not expected.This event is being reported as a worst-case event for the od.The event for the os will be submitted in a separate report.A lot history review was performed for lot 3801170934: 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 3801170934 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 DEFINE
• 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: 6838069
• MDR Text Key: 84351420
• Report Number: 9617710-2017-05038
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2018
• Device Catalogue Number: 1DD
• Device Lot Number: 3801170934
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2013
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention