MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. - US 1-DAY ACUVUE® MOIST®; LENSES, SOFT CONTACT, DAILY WEAR

Catalog Number 1DM

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

Patient Problems Corneal Ulcer (1796); Dry Eye(s) (1814); Foreign Body Sensation in Eye (1869); Eye Pain (4467)

Event Date 01/01/2022

Event Type  Injury  

Manufacturer Narrative

Suspect product was discarded.

Event Description

On 08apr2022, a patient (pt) called to report while wearing 1-day acuvue® moist® brand contact lenses (cls), the pt experienced difficulty ¿clicking¿ apart the lens packages from the foil strip causing the foil to tear.The pt advised the foil would ¿sometimes tear¿ on more than one package causing the solution to dry up.The pt reported a diagnosis of corneal ulcers in both eyes in (b)(6) 2022 because the pt may have used a cl that may not have been sterile due to this issue.The pt called an eye care professional (ecp) in (b)(6) 2022 due to pain in both eyes (ou) with ¿a feeling of something in her eyes as if they were scratched¿ and was diagnosed with ou ulcers over the phone.Two prescription eye drops (medication is unknown) were called in by the ecp for use in both eyes for 10 days.The pt reported both eyes felt better within 2-3 days, but continued to use the drops for 10 days.The pt reported wearing cls daily from ¿6am to 12am¿ and both eyes dry out from ¿looking at the computer all day.¿ the ecp advised the pt to wear glasses more often to give the eyes a break from cl wear.The pt stated both eyes have ¿been fine¿ since (b)(6) and did not know if the ulcers were related to the packaging issues.The pt declined to provide ecp contact information and refused to provide any additional information.This event will be submitted as an os worst-case event as we were unable to verify the pt¿s diagnosis and treatment with the ecp.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 6125040102 was produced under normal conditions.This report is for the pt¿s os event.The report for the pt¿s od event will be filed as a separate report.The suspect os cl was not available for return for evaluation.No additional evaluation can be conducted.No further information is expected.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: 1-DAY ACUVUE® MOIST®
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. - US; 7500 centurion parkway; jacksonville FL 32256
• Manufacturer Contact: helene aguilar ; 7500 centurion parkway; jacksonville, FL 32256 ; 9047429918
• MDR Report Key: 14193962
• MDR Text Key: 293168791
• Report Number: 1057985-2022-00030
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 1DM
• Device Lot Number: 6125040102
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2021
• 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): Other; Required Intervention
• Patient Sex: Female