MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US ACUVUE VITA; SOFT CONTACT LENS, DAILY WEAR

Catalog Number ATL

Device Problem No Apparent Adverse Event (3189)

Patient Problems Unspecified Infection (1930); Pain (1994); Red Eye(s) (2038); Swelling (2091)

Event Date 09/03/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2017 a patient (pt) called our affiliate in (b)(6) to report he/she experienced red eyes and sore eyes while wearing the acuvue vita brand contact lenses.The pt reported the eyes were still red after removing the suspect lenses, but stated the eyes are getting better.The pt reported he/she did not seek medical attention.The pt reports he/she is a new wearer.The pt reported 2 suspect lenses are available for return.On (b)(6) 2017 the pt called and additional information was provided as follows: the pt reported he/she visited the eye care provider (ecp) at an eye clinic.Pt reported the ecp recommended the pt not use contact lenses anymore.Pt reported his/her ¿eyes got infection, swollen and redness¿.Pt reported using levofloxacin eye drops, flumetholon ophthalmic suspension; dibrufen tab, retonase tab and cefacli cap.The pt reported using the eye drops four times daily and he/she takes the pill three times daily.The pt reported the right eye is more severe.The pt refused to return the suspect product.Pt reported he/she will provide the medical report by email.On (b)(6) 2017 a call was placed to the pt who reported the eyes are better, but he/she still had discomfort.The pt reported he/she has not sent the medical report yet.On (b)(6) 2017 a call was placed to the pt to check on the pts eye condition and request the medical report, but nothing additional has been received.The date of event is reported as (b)(6) 2017.No additional medical information has been received.Additional medical information has been requested.This report is for the pts os event.The pts od event will be submitted in a separate report.This event is being filed as a worst-case os event as the pt reported he/she was unable to return to contact lens wear.The diagnosis and treatment were unable to be verified with the pts treating ecp.A lot history review was performed for lot b00ng95: 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 b00ng95 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 23oct2017 our affiliate in (b)(6) received additional information from the patient (pt): pt reported presenting to an eye care provider (ecp) three times and a visit to the hospital.Pt advised that "my cornea has still not fully recovered." pt reported "i do not know when i can return to wearing lenses." pt provided copies of hospital receipts with dates of treatment and names of medications: receipt for treatment for outpatient eye clinic: treatment duration (b)(6) 2017.Receipt for medication: date of prescription (b)(6) 2017, cefaclo cap 250 ml, letona tab 10 mg, diprofen tab 0.3g, levopecin drop 25mg/5ml, fluometholone 0.2% drop.Receipt for treatment for outpatient eye clinic: treatment duration: (b)(6) 2017.Receipt for treatment for outpatient eye clinic: treatment duration: (b)(6) 2017.The suspect product was requested for return, but it has not been received.No additional medial information has been received.If additional information is received it will be reported within 30 days of receipt.

• Brand Name: ACUVUE VITA
• Type of Device: SOFT CONTACT LENS, DAILY 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: 6911722
• MDR Text Key: 88123253
• Report Number: 1057985-2017-00118
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: KN
• PMA/PMN Number: K160212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/23/2017

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: 06/01/2022
• Device Catalogue Number: ATL
• Device Lot Number: B00NG95
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/12/2017
• Initial Date FDA Received: 10/03/2017
• Supplement Dates Manufacturer Received: 10/23/2017
• Supplement Dates FDA Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2017
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention