MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE - IRELAND ACUVUE OASYS®1 DAY WITH HYDRALUXE¿ TECHNOLOGY; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number TSP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 11/01/2021

Event Type  Injury  

Event Description

On (b)(6) 2021 an eye care provider (ecp) in (b)(6) called to report a patient (pt) had an ¿eye infection¿ in the os while wearing the acuvue® oasys 1-day with hydraluxe® brand contact lens (cls).The event occurred ¿sometime this week¿, (b)(6) 2021.The pt went to a doctor who prescribed an unknown ¿antibacterial eye drop.¿ the ecp ¿thinks¿ the pt had a ¿bacterial eye infection¿ but can¿t be sure.The pts os is currently fine.No additional medical information was provided.On (b)(6) 2021 a call was placed to the pts reporting ecp who advised the pt does not wish to be contacted.The ecp will call the pt to see if the pt will provide any additional medical information.No additional medical information is known.This event is being reported as a worst-case event as we were unable to verify the pts diagnosis and treatment.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 6311720101 was produced under normal conditions.The suspect os cls was discarded.No additional evaluation can be conducted.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

Suspect product discarded.

• Brand Name: ACUVUE OASYS®1 DAY WITH HYDRALUXE¿ TECHNOLOGY
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE - IRELAND; 1 technological park plassey; limerick LK130 01; EI LK13001
• Manufacturer Contact: helene aguilar ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433835
• MDR Report Key: 13014080
• MDR Text Key: 287697840
• Report Number: 1057985-2021-00176
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K042275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2021

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: 10/01/2023
• Device Catalogue Number: TSP
• Device Lot Number: 6311720101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/26/2021
• Initial Date FDA Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other