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); Eye Pain (4467)

Event Date 10/01/2021

Event Type  Injury  

Manufacturer Narrative

Suspect product not available.

Event Description

On (b)(6) 2022, a patient (pt) called to report a diagnosis of corneal ulcers in both eyes in (b)(6) 2021 while wearing 1-day acuvue® moist® brand contact lenses (cls).The pt visited an eye care professional (ecp) following a night of severe pain in (b)(6) 2021 and was diagnosed with an ulcer in the left eye (os).The pt was advised not to wear cls for 2-3 weeks and used two different eye drops, including an antibiotic, but did not recall the names or dosage of the drops.At the one-week follow-up, the pt was also diagnosed with an ulcer in the right eye (od) and used the same two unknown eye drops in the od (dosage unknown).The pt reported wearing cls daily from ¿6 am to 12 am,¿ both eyes dry out from ¿looking at the computer all day,¿ and was advised by the ecp to wear glasses more often to give ou a break from cl wear.The pt stated both eyes are ¿fine now,¿ declined to provide ecp contact information, and refused to provide any additional information.This event will be submitted as a worst-case ou event as we were unable to verify the pt¿s diagnosis, date of event and treatment with the ecp.The lot number of the od suspect product is unknown.This report is for the pt¿s od event.The report for the pt¿s os event will be filed as a separate report.The suspect od cl is 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: 14188433
• MDR Text Key: 289890094
• Report Number: 1057985-2022-00027
• 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: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 1DM
• 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
• 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
• Patient Sex: Female