MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE - IRELAND ACUVUE® 2® DEFINE¿; LENSES, SOFT CONTACT, EXTENDED WEAR

Catalog Number A2D

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

Patient Problems Keratitis (1944); Red Eye(s) (2038)

Event Date 08/01/2022

Event Type  Injury  

Event Description

On 13 oct 2022, a patient (pt) in china called to report the right eye (od) and left eye (os) were red while wearing the acuvue ®2 ® define¿ brand contact lenses (cl) in (b)(6) 2022.The pt reported after removing the suspect od and od cl, the redness continued so the pt sought medical attention.The pt reported that an eye care professional (ecp) at a hospital diagnosed keratitis ou and prescribed norofloxacin eye drops every 2 hours, 2 to 3 drops at a time and another eye gel (name was unknown) prescribed twice daily.The pt advised both eyes were fine after a week.The pt reported the medical report is not available as a medical report was not provided to the pt at the hospital.No additional medical information has been received.This os keratitis event is being reported as a worst-case as we were unable to verify the pt¿s diagnosis and treatment.A lot history review was performed and revealed the following: the batch records did not show any abnormalities in monomer and solution testing.All parameters tested were within specification.All sterilization requirements were successfully completed.Lot number 3642960104 was produced under normal conditions.The os suspect 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® 2® DEFINE¿
• Type of Device: LENSES, SOFT CONTACT, EXTENDED 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 ; 9047429918
• MDR Report Key: 15714253
• MDR Text Key: 302841167
• Report Number: 1057985-2022-00085
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/02/2022

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 Catalogue Number: A2D
• Device Lot Number: 3642960104
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2022
• Initial Date FDA Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2021
• 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