MAUDE Adverse Event Report: JOHNSON AND 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 Conjunctivitis (1784); Unspecified Infection (1930); Irritation (1941); Itching Sensation (1943); Keratitis (1944); Red Eye(s) (2038)

Event Date 05/09/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On 09may2017 a patient (pt) called our affiliate in (b)(4) to report that while wearing the 1-day acuvue define brand contact lenses he/she experienced right eye redness and itching.The pt reported on insertion of the suspect lens, the pt noted a stinging sensation.The suspect lens was removed.The pt stated that he/she had an appointment with the eye care provider (ecp) (b)(6)2017 for evaluation.On 10may2017 the pt called and additional information was provided: pt reports diagnosis of keratitis and conjunctivitis and was prescribed tarivid eye drop, flumetholon ophthalmic suspension 0.1, and hamerone a eye drop 4 times a day; pt reports follow-up appointment and will provide an update.The pt reported that he/she had an additional follow-up visit on (b)(6) 2017 and provided additional information: pt reported that the eye is still red and will follow-up with the ecp again next week.No additional medication was prescribed.Pt reported he/she was advised not to return to contact lens wear ¿up to 3 weeks after the eye is fully recovered.¿ the pt reported a follow-up appointment on (b)(6) 2017 and provided additional information: pt reports that the eye is still red and was advised by the ecp to continue to use the same eye drops until the return visit for an eye check again later in the week.On 22may2017 the pt reported a follow-up visit with the ecp on (b)(6) 2017 and advised the ecp indicated the treatment was completed for the ¿infection.¿ pt reported that the eye is still a bit red and the ecp advised that ¿part of the blood vessel had been expanded, cause red eye, which is incurable.¿ pt reported that he/she could not provide the medical record.On 22may2017 a return call was placed to the pt and additional information was obtained as follows: pt reported that he/she had ¿conjunctivitis and keratitis together.¿ the pt also reported that he/she tried the affected lens on the left eye and had the ¿same symptoms¿ but indicated that the ¿left eye was not serious.¿ the left eye was also affected on the (b)(6) 2017.On (b)(6) 2017 the pt reported that he/she tried trial lenses for acuvue oasys 1-day without issue.No additional medical information has been received and no additional medical information is expected.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 3325240762 was produced under normal conditions.The suspect product was requested for return, but it has not yet been received.This submission is for the pts os event.The od event will be submitted in a separate report.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 AND JOHNSON VISION CARE, INC. - IRELAND; one technological park plassey; limerick ; EI
• Manufacturer Contact: rose harrell ; 7500 centurion park blvd.; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 6641840
• MDR Text Key: 77610919
• Report Number: 9617710-2017-05012
• 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: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2021
• Device Catalogue Number: 1DL
• Device Lot Number: 3325240762
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention