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

Catalog Number 1D4

Device Problem No Apparent Adverse Event (3189)

Patient Problems Bacterial Infection (1735); Corneal Ulcer (1796); Foreign Body Sensation in Eye (1869); Inflammation (1932); Pain (1994); Red Eye(s) (2038)

Event Date 10/19/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2017 a patient (pt) called the affiliate in (b)(6) to report a foreign body sensation in the left eye while wearing a 1-day trueye brand contact lens.After the suspect lens was removed, the pt experienced pain and redness.On (b)(6) 2017 the pt went to an eye care provider (ecp) and was diagnosed with ¿inflammation¿ in the left eye.The pt reported he/she was advised to discontinue contact lens wear and return to the clinic on (b)(6) 2017.Pt was prescribed levofloxacin ophthalmic solution and tarvid eye ointment.The pt reported the symptom is improving.On (b)(6) 2017, a call was placed to the pt and additional medical information was obtained: pt reported the eye was getting better and instructed to return to the clinic on (b)(6) 2017.Pt was prescribed levofloxacin ophthalmic solution every two hours.On (b)(6) 2017, a call was placed to the pt and additional medical information was obtained: on (b)(6) 2017 the pt returned to the clinic and was advised the eye was getting better; no problem with the va.The pt has not been allowed to return to contact lens wear.Pt was advised to return to the clinic in one week.On (b)(6) 2017 a medical interview was held with the pts treating ecp and additional information was obtained: on (b)(6) 2017 the pt presented to the ecp with complaints of pain and redness; diagnosis: corneal ulcer, infectious; culture: not conducted; focal site and size: superior part of the cornea, slightly on the pupil; symptom: redness os; va affect: va could not be measured since the pain was severe; treatment: cravit ophthalmic solution 1.5% every 1-2 hours, tarivid eye ointment prn and before bedtime; discontinuation of cl wear: instructed rtc: instructed on (b)(6) 2017.Follow-up visit: (b)(6) 2017 outcome: improvement; treatment: cravit ophthalmic solution 1.5% every 1-2 hours, tarivid eye ointment prn and before bedtime; discontinuation of cl wear: instructed; rtc: instructed after (b)(6) 2017.Follow-up visit:(b)(6) 2017 outcome: improvement, no problem with va; treatment: cravit ophthalmic solution 1.5% 6 times/day, tarivid eye ointment discontinued; discontinuation of cl wear: instructed; rtc: instructed in a week.Follow-up visit: (b)(6) 2017 outcome: recovery; treatment: finish up cravit ophthalmic solution 1.5% 6 times/day and tearbalance discontinuation of cl wear: not instructed no additional medical information has been received.The suspect product was discarded.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 5827440105 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.

Manufacturer Narrative

On 21nov2017, our affiliate in (b)(6) received a copy of the medical report from the patient's (pt) treating eye care provider (ecp): report date: 17nov2017.Diagnosis: corneal ulcer os.Seriousness: not serious.Causal relationship with cl: cannot be denied.Outcome: recovery.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. ¿ IRELAND; one technological park plassey; limerick ; EI
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 7042179
• MDR Text Key: 92470725
• Report Number: 9617710-2017-05058
• 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,health profe
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/21/2017

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: 05/01/2022
• Device Catalogue Number: 1D4
• Device Lot Number: 5827440105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/20/2017
• Initial Date FDA Received: 11/17/2017
• Supplement Dates Manufacturer Received: 11/21/2017
• Supplement Dates FDA Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2017
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 42 YR