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

Catalog Number TSP

Device Problem No Apparent Adverse Event (3189)

Patient Problems Bacterial Infection (1735); Conjunctivitis (1784); Red Eye(s) (2038)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2018 a patient (pt) in (b)(6) sent an email to the affiliate and reported redness after wearing the acuvue oasys 1-day brand contact lenses.The pt went to an eye care provider (ecp) who diagnosed the pt with purulent conjunctivitis and prescribed treatment (details were not provided).On (b)(6) 2018 an email was received with additional information as follows: the event date is reported as early (b)(6) 2018 and both eyes were affected.Diagnosis: purulent conjunctivitis.Pt was prescribed oftalmoferon and okomistin eye drops (the frequency of the treatment was not provided) for 2 weeks.The pt has no current symptoms.On (b)(6) 2018 an email was received with additional information: the oftalmoferon was prescribed 5-6 times per day and the okomistin was prescribed 3-4 times per day.No additional medical information was received.This report is for the pts left eye event.The event for the pts right eye will be submitted in a separate report.The suspect lens is not 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 5526830104 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. ¿ IRELAND; one technological park plassey; limerick ; EI
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 7238113
• MDR Text Key: 98966000
• Report Number: 9617710-2018-05011
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K042275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/09/2018

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: 12/01/2021
• Device Catalogue Number: TSP
• Device Lot Number: 5526830104
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/09/2018
• Initial Date FDA Received: 02/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention