MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US ACUVUE OASYS; LENSES, SOFT CONTACT, EXTENDED WEAR

Catalog Number PH

Device Problem No Apparent Adverse Event (3189)

Patient Problems Corneal Ulcer (1796); Discomfort (2330)

Event Date 11/29/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2017 a patient (pt) from (b)(6) called to report that the acuvue oasys brand contact lenses were not lasting the recommended time and the lenses are breaking.The pt also reported he/she was not at home and did not have the lot number or the eye care provider¿s contact information.The pt reported the suspect lenses were discarded.On 05dec2017 a call was placed to the pt and additional information was obtained as follows: the pt reported the initial call was to report a lens that a lens tore when handling.On (b)(6) 2017, the following day, pt experienced left eye pain and a piece of the lens came out.The pt went to an urgent care center on (b)(6) 2017 and was diagnosed with a corneal ulcer in the left eye.Pt was prescribed antibiotic q 1 hour for one day, then q 2 hours.The pt reported he/she is still using the eye drops every 2 hours.Pt reported 3 doctor visits for the event.Pt reported a follow-up visit with the ophthalmologist on (b)(6) 2017.Pt reported a two-week replacement schedule and does not sleep in the lenses.Pt uses renu moisturizing drops, but did not have the name of the solution used to disinfect and clean the lenses.On (b)(6) 2017 the pt reported he/she has not had time to email the eye care providers (ecp) contact information.Pt had follow-up visit with the ophthalmologist on (b)(6) 2017 who told the pt the left eye ulcer has healed and the pt could return to contact lens wear for a couple of hours a day.The pt reported he/she is planning a return visit to the ecp today due to discomfort with the contact lens even for short-time.No additional medical information was provided.On (b)(6) 2017 an email was received from the pt and additional information was provided: on (b)(6) 2017 reported a follow-up visit at the clinic the pt usually visits; pt had 3 follow-up visits and ecp reported observed improvements in the ulcer of the left eye.The pt reported he/she was instructed to use contact lenses less and alternate with glasses.Pt reports next visit is scheduled on (b)(6) 2018.On 14dec 2017 an email was received from the pt and additional information was provided: ¿i want to inform you that when i went back to using the lenses a few days later they damaged again, causing discomfort in my eyes.I have a damaged lens so you can check it.I'm going on a trip for 10 days.¿ no additional information was received.On 21dec2017 an email was received from the pt and additional information was provided: pt reported he/she will be going on vacation and on the pts return will return the call.Pt reports he/she was authorized to use lenses for much less time and alternates with use of glasses and feel much better.On (b)(6) 2018 pt reports a follow-up visit with the ecp.Multiple attempts were made to the pts treating ecp for additional information, but no additional information has been received.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 b00lqlp 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

During a file review it was noted that in section the country for the initial reporter is listed as (b)(6).The correct country information for the initial reporter is (b)(6).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: ACUVUE OASYS
• Type of Device: LENSES, SOFT CONTACT, EXTENDED WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ US; 7500 centurion parkway; jacksonville FL
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 7154386
• MDR Text Key: 96044081
• Report Number: 1057985-2017-00150
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: P040045
• 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: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• 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: PH
• Device Lot Number: B00LQLP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2016
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention