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 Irritation (1941); Uveitis (2122); Blurred Vision (2137)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter¿s phone number: (b)(6).

Event Description

On (b)(6) 2018 an email was received from a patient (pt) in (b)(6) reporting excessive movement, uneven color print and experienced irritation after insertion of the 1-day acuvue® define¿ with lacreon® brand contact lenses.The pt is an experienced wearer.The pt reported the event date as (b)(6) 2018.On (b)6) 2018 the pt reported the eye care provider (ecp) has not diagnosed the pt with uveitis, but the pt feels the ¿symptoms are similar¿ to a previous event.On (b)(6) 2018 the pt went to the emergency room visit (b)(6) 2018.Pt reported a diagnosis of uveitis in the od.The pt was prescribed steroid eye drops every hour for three hours, then reduce to once every two hours.The pt has a follow-up appointment with the ecp on (b)(6) 2018.The pt will send the medical documents.On (b)(6) 2018 an email was received from the pt with pharmacy receipt, prescription, and follow-up appointment letter.Pt reported the symptoms worsened on (b)(6) 2018 and the pt went to the hospital.Prescription dated (b)(6) 2018 for pred forte re qid for 1 month; cyclopentolate 1% re tds for 1 month; maxidex re nocte for 2 op.A follow-up appointment letter for (b)(6) 2018 with ecp @ 1:00pm.On (b)(6) 2018 an email was received from the pt who reported he/she contacted the treating ecp, but the ecp has not responded.On (b)(6) 2018 an email was received from the patient (pt) who provided a hospital medical record dated (b)(6) 2018: pt was referred to the hospital due to possible uveitis ou; pt was diagnosed with recurrence of right anterior/immediate uveitis; no medications were prescribed; pt complained of 1 week of floaters and blurred vision and a few weeks of discomfort; exam noted ac +1 cells and viritis +2 cells; plan included g pf q 1 hour for 3 days, g cyclo tds, return to clinic next week; ¿va measured 6/8.6 od¿.On (b)(6) 2018 a call was placed to the patient (pt) and additional information was provided: pt missed doctor¿s appointments due to (b)(6) holidays, but plans to make another visit soon.Pt reported that the symptoms are subsiding.On (b)(6) 2018 additional information was received from the pt: pt reported that the lenses were returned for evaluation.Pt reported that her eye condition has been getting better with ¿irritations settling down¿.Pt reported the uveitis condition has ¿settled down¿ and pt doesn¿t plan to further visit her doctor on that matter.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 3425230458 was produced under normal conditions.No additional medical information has been received.No additional information is expected.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: 7422901
• MDR Text Key: 105240992
• Report Number: 9617710-2018-05029
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2018

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: 12/01/2020
• Device Catalogue Number: 1DL
• Device Lot Number: 3425230458
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/16/2018
• Initial Date FDA Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention