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 No Apparent Adverse Event (3189)

Patient Problems Bacterial Infection (1735); Keratitis (1944); Red Eye(s) (2038)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2017 a patient (pt) notified a johnson and johnson employee, eye care provider (ecp), to report while wearing the 1-day acuvue moist for astigmatism brand contact lenses an ecp diagnosed the pt with bacterial keratitis in both eyes.The pt was prescribed vancomycin 1 drop each eye every hour.The pt texted photos of the eyes to the johnson and johnson employee ecp who noted that the pt has a little sectoral limbal injection and a possible conjunctival cyst; no bulbar injection, lid edema or discharge.No additional information was received.On 01dec2017 an email was received from the johnson and johnson ecp who reported speaking with the pt and provided additional information: the pt reported wearing the contact lenses about 14 hours daily.Pt is a medical student and has not been washing hands when inserting the lenses.The pt also has a gonioscopy lens in and out of the eyes frequently and does not believe the event is due to the contact lens.No discharge or corneal infiltrate.The pt declined further contact for additional medical or product information.The date of the event was not provided.The lot number was not provided and it is unknown if the suspect lenses were available for return.This report is for the pts left eye event.The event for the pts right eye will be provided in a separate report.If additional information is received it will be reported within 30 days of receipt.Serious reportable event trends are reviewed quarterly in franchise management review meetings.

• 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: 7142296
• MDR Text Key: 95665499
• Report Number: 1057985-2017-00148
• 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: company representative,consum
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 1MA
• Device Lot Number: UNK-1MA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention