MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US ACUVUE OASYS1 DAY WITH HYDRALUXE TECHNOLOGY; LENSES, SOFT CONTACT

Catalog Number TSP

Device Problem No Apparent Adverse Event (3189)

Patient Problems Irritation (1941); Pain (1994); Red Eye(s) (2038)

Event Date 01/02/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2018 an eye care provider (ecp) in (b)(6) reported a patient (pt) had ¿used a daily lens due to the lack of usual monthly lens¿ shortly after placing the lens the pt experienced a stinging sensation which escalated to sharp pain¿.The pt sought medical assistance with an ecp ¿who could see damage to conjunctiva and scraping of cornea.Lens rest and citodon¿.New appointment on (b)(6) 2018, ecp ¿suspects toxicity of cornea¿.Prescribed opnol and was given and appointment for follow-up.The suspect product was reported as acuvue oasys 1 day brand contact lenses.On 23jan2018 a call was placed to the pts optometrist and additional medical information was provided: both eyes were affected.Pt told the optometrist no solution had been used in combination with the lenses prior to insertion.Additional information was requested.On 29jan2018 additional information was received from the affiliate in (b)(6): the patient visits the hospital on (b)(6) 2018.¿the pt suffers from blurred vision since the day before.The pt inserted the daily disposables for the first time, but the blurriness still remained, the pt took out the lenses and immediately felt pain in the left eye and is not able to open the eye¿.Pt experienced photophobia.Pt reported no trauma involved.When removing the contact lens in the left eye, irritation and erosion were visible.Irritation were found in the right eye as well, but no erosion.Pt had a follow-up visit a few days later: left eye is ok, still irritation in the right eye.Finding according to the ecp is that the right eye has no ¿pus¿, but moderate bulbar hyperemia.Small clouding in corneal stroma.Oedema.Left eye is now good with clear, transparent cornea.Doctor suspect toxicity caused by the contact lenses.Treatment is opnol x3 (cortison)¿.No additional information was provided.No additional information has been received.This report is for the pts left eye event.The event for the pts right eye will be submitted in a separate report.It is unknown if the suspect product is available for return.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 5520870101 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.

• Brand Name: ACUVUE OASYS1 DAY WITH HYDRALUXE TECHNOLOGY
• Type of Device: LENSES, SOFT CONTACT
• 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: 7278116
• MDR Text Key: 100310735
• Report Number: 1057985-2018-00018
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K042275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2018
• 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: TSP
• Device Lot Number: 5520870101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention