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); Pain (1994)

Event Date 11/20/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2017, our affiliate in (b)(6) was contacted by a patient (pt) who reported difficulty removing a pair of acuvue oasys®1 day with hydraluxe¿ technology contact lenses on (b)(6) 2017.Pt reported experiencing pain in both eyes after the lenses were removed.Pt presented to an eye care provider (ecp) on (b)(6) 2017 and was advised ¿bacteria got into the eyes¿ which was ¿not severe.¿ pt was instructed to discontinue lens wear for a week.Pt was advised a follow up was not necessary unless the pt felt pain.Pt reported he/she was not currently experiencing pain ou.Pt was prescribed levofloxacin ophthalmic solution and diquas ophthalmic solution.Pt reported the ou condition ¿has been poor¿ since he/she started wearing the lenses and is considering switching to another product.On 28nov2017, our affiliate was contacted by the pt who provided additional information: pt reported returning to the ecp on (b)(6) 2017 and was cleared for lens wear as the pt¿s symptoms ou had resolved.Pt is considering switching to another product due to the difficulty in removing the acuvue oasys®1 day with hydraluxe¿ technology lenses and was advised by ecp to ¿wear the lenses that fit to the pt¿s eyes.¿ the product in question was discarded and is not available for return.No additional information has been received.No additional information is expected.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 5521420112 was produced under normal conditions.This report is for the pt¿s right eye.The report for the pt¿s left eye will be filed in a separate report.This event is being reported as a worst-case event.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: 7121553
• MDR Text Key: 94979953
• Report Number: 9617710-2017-05071
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K042275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/22/2017

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: 01/01/2021
• Device Catalogue Number: TSP
• Device Lot Number: 5521420112
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/22/2017
• Initial Date FDA Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2016
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention