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

Catalog Number 1MA

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

Patient Problems Bacterial Infection (1735); Irritation (1941); Red Eye(s) (2038)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2019 a patient (pt) from (b)(6) called to report eye "infections", irritation and red eyes while wearing the 1-day moist for astigmatism brand contact lenses.The pt went to an eye care provider (ecp) in 2018 and was diagnosed with bacterial infection ou.The pt was prescribed besivance ophthalmic 1 drop tid for 7 days with no contact lens wear.The pt has been unable to wear the lenses for the entire day and reported the eyes are better after the suspect lenses are removed.No additional medical information was provided.On 19mar2019 a call was received from the pt who refused to provide any additional information.This report is for the pt¿s od event.The event for the pt's os event will be submitted in a separate report.This event is being submitted as a worst-case event as the diagnosis and treatment were unable to be verified with the pt¿s treating ecp.No additional medical 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 1988060101 was produced under normal conditions.The suspect od lens was discarded and is not available for return.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: 1-DAY ACUVUE MOIST FOR ASTIGMATISM
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. ¿ US; 7500 centurion parkway; jacksonville FL
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433364
• MDR Report Key: 8464545
• MDR Text Key: 140330466
• Report Number: 1057985-2019-00030
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2023
• Device Catalogue Number: 1MA
• Device Lot Number: 1988060101
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention