MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US ACUVUE VITA; SOFT CONTACT LENS, DAILY WEAR

Catalog Number ATL

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

Patient Problems Keratitis (1944); Red Eye(s) (2038); Discharge (2225)

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

On (b)(6) 2020, a patient (pt) in (b)(6) reported a diagnosis of keratitis od while wearing an acuvue® vita¿ brand contact lens.The pt experienced redness and discharge in the od while wearing one contact lens in (b)(6) 2020.The pt¿s od was still red upon removal of the lens.The pt visited the eye care provider (ecp) and was diagnosed with keratitis od.The pt was prescribed levofloxacin eye drops to use every hour and chlortetracycline hydrochloride eye ointment to use before bed.On 10aug2020, additional information was received from the pt: the pt reported that the ecp advised that there is a ¿possibility of scarring on cornea.¿ the pt will return to the ecp for a follow-up next week.No further information was provided.On 12aug2020, additional information was received from the pt: the pt reported that the medications changed to levofloxacin eye drops to use 3-4 times a day; levofloxacin eye gel once before bed; chlortetracycline hydrochloride eye ointment was discontinued.The pt was willing to provide the medical report when the symptoms resolve.The pt was unable to provide any further information.No additional medical information has been received.The suspect od contact lens was discarded.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 b00v7tw was produced under normal conditions.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: ACUVUE VITA
• Type of Device: SOFT CONTACT LENS, 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: 10443067
• MDR Text Key: 204238166
• Report Number: 1057985-2020-00042
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K160212
• 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: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: ATL
• Device Lot Number: B00V7TW
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention