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

Catalog Number 1DL

Device Problem No Apparent Adverse Event (3189)

Patient Problems Dry Eye(s) (1814); Inflammation (1932); Pain (1994); Discomfort (2330)

Event Date 08/08/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2017, our affiliate in (b)(4) received a call from a patient (pt) who reported experiencing pain and discomfort in while wearing 1 day acuvue define with lacreon contact lenses.Pt reported the event occurred on (b)(6) 2017.Pt reported he/she will present to a doctor.On 09aug2017, a call was placed to the pt who reported the event occurred with the left eye (os).Pt declined to return the product in question.On 09aug2017, an email as received from the pt who reported he/she cannot wear contact lenses for seven days due to eye inflammation and a ¿corneal scratch.¿ pt reported being prescribed q-levox eye drops (levofloxacin) and fluorometholone.Eye drops 0.1% (fluorometholone), both to be used ¿every 4 hours for 4 x per day.¿ pt reported he/she will have a follow up with the doctor in 7 days.Pt also provided a copy of the medical receipt.The medical receipt reported the pt was prescribed q-levox eye drops (levofloxacin) and fluorometholone eye drops 0.1% (fluorometholone) to be used 1 drop once a day x 1 day.On 11aug2017, a call was placed to the pt who reported he/she will go to the doctor for follow up and will provide a copy of the medical certificate.On (b)(6) 2017 an email was received from the pt with the medical report.Additional information as follows: date of diagnosis: (b)(6) 2017.Medical diagnosis: idiopathic keratoconjunctivitis; keratoconjunctivitis sicca (non sjogren) dry eye.Treatment and prognosis: on (b)(6) 2017, the above patient has been counselled regarding his/her pain and discomfort on the le.From an examination of the anterior part, a damaged cl was noticed.The patient¿s being treated with keratoconjunctivitis currently and requires a regular monitoring with treatment.This condition is limited to ophthalmological condition.The product in question was not returned.No additional medical information has been received.A lot history review was performed for lot 2435820107: 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 2435820107 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 WITH LACREON
• 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: 6834755
• MDR Text Key: 84249923
• Report Number: 9617710-2017-05036
• 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: 08/09/2017

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: 04/01/2021
• Device Catalogue Number: 1DL
• Device Lot Number: 2435820107
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/09/2017
• Initial Date FDA Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2016
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention