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 Conjunctivitis (1784); Keratitis (1944); Blurred Vision (2137); Discomfort (2330)

Event Date 08/28/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2017 a patient called our affiliate in (b)(6) to report while wearing the 1-day acuvue define with lacreon the pt experienced blurry vision and contact lens movement on both eyes.The pt reported he/she is a new user.The pt reported the event date was (b)(6) 2017.The pt stated he/she was not currently wearing lenses and is experiencing photophobia and foggy vision.The pt went to an eye care provider (ecp) on (b)(6) 2017 and advised the pt he/she had ¿corneal injuries¿.The pt was prescribed levofloxacin eye drops, levofloxacin eye ointment, and acyclovir eye drops.The suspect lenses were discarded.On (b)(6) 2017 a call was placed to the pt and additional information was provided: the pt reported the diagnosis from the ecp was superficial punctate keratitis; pt was advised to use levofloxacin eye drops and acyclovir eye drops every 2 hours, levofloxacin eye ointment every night.The medical report was requested.On 06sep2017 a call was placed to the pt and the additional information was provided: the pt reported he/she had a follow-up visit with the ecp on (b)(6) 2017; pt reported the ecp advised the left eye was fine, but exfoliation of corneal epithelium was noted on the right eye; sodium hyaluronate eye drops were added to her treatment, 4 times a day; frequency of levofloxacin eye drops and acyclovir eye drops has been reduced to twice a day; pt reported his/her eyes feel ok now; pt agreed to provide copy of medical report.On 15sep2017 a phone call was placed to the pt and the additional information was provided: the pt reported the previous symptoms were gone, however, the pt feels the visual acuity in the right eye had worsened.The pt will go for a follow-up eye check tomorrow.The medical report was requested.This report is for the pt's left eye event.The pt's right eye event will be submitted in a separate report.No additional medical information was received.Additional medical information was requested.A lot history review was performed for lot number 3623430766 which 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 3623430766 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 (b)(6) 2017, the pt provided a copy of the medical report by email.On (b)(6) 2017, the medical report translation was received and additional medical information provided: date of visit: (b)(6) 2017.Chief complaint: photophobia and discomfort for 2 days.Physical examination: ou conjunctival congestion (++), corneal epithelia diffuse punctate loss, fluorescein staining (+), rest of anterior segment (-), visual acuity: r 0.3, l 0.2, nct: r 15.6 mmhg, l 13.9 mmhg.Diagnosis: ou punctate keratitis.Prescription: levofloxacin eye drop, ou qid, aciclovir eye drop, ou qid, diclofenac sodium eye drop, ou qid, rest for 3 days.Date of visit: (b)(6) 2017.Return visit physical examination: ou conjunctival congestion (++), od corneal epithelia loss and fluorescein staining (+), os fluorescein staining (-), ou anterior chamber (-), pupil (-).Diagnosis: ou punctate keratitis prescription: more attention to rest continue to use eye drops (can not identify), ou qid.Date of visit: (b)(6) 2017.Rest visit for ou corneal keratitis physical examination: corrected visual acuity: r 1.0, l 1.0 ou conjunctival congestion, corneal transparent, anterior chamber clear, tyn¿s(-), pupil round, (can not identify), (can not identify).Iop: tn.Diagnosis: ou conjunctivitis.Prescription: follow-up visit.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.(b)(4).

• 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: 6887934
• MDR Text Key: 87217650
• Report Number: 9617710-2017-05044
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 09/28/2017

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: 06/01/2021
• Device Catalogue Number: 1DL
• Device Lot Number: 3623430766
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/29/2017
• Initial Date FDA Received: 09/22/2017
• Supplement Dates Manufacturer Received: 09/28/2017
• Supplement Dates FDA Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2016
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention