MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. ¿ US ACUVUE OASYS; LENSES, SOFT CONTACT, EXTENDED WEAR

Catalog Number PH

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

Patient Problems Unspecified Infection (1930); Itching Sensation (1943); Red Eye(s) (2038); Swelling (2091); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

On (b)(6) 2019, during a johnson and johnson vision care quality survey, a patient (pt) in (b)(6) reported experiencing itchy, red and swollen eyes whiles wearing acuvue® oasys® brand contact lenses (cl).Pt presented to an eye care professional (ecp) who advised the pt to discontinue cl wear and start treatment.Pt reporting returning to cl wear after treatment was completed.Pt is a new user to the acuvue brand.On (b)(6) 2019, the pt was contacted and provided additional information: pt reported od redness and discomfort with the second cl on the second day of wear.Pt reported presenting to an ecp and being diagnosed with an ¿infection¿ in the right eye (od).Pt reported being prescribed moflox eye drops q3hr x 1 week.Pt returned to the ecp for a follow up visit after treatment and was cleared to return to cl wear.Pt reported the event resolved and is wearing cls with no issue.Pt reported a monthly wear schedule and does not sleep in lenses.Pt refused to provide the medical record.Pt discarded the suspect lenses.Multiple attempts were made to the pt for the name of the treating ecp to obtain additional medical information.No additional information has been received.This is being reported as a worst case as the pt¿s diagnosis and treatment were unable to be verified.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 b00qcwn was produced under normal conditions.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: ACUVUE OASYS
• Type of Device: LENSES, SOFT CONTACT, EXTENDED 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: 8758197
• MDR Text Key: 150260144
• Report Number: 1057985-2019-00060
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• Reporter Country Code: AR
• PMA/PMN Number: P040045
• 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: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2023
• Device Catalogue Number: PH
• Device Lot Number: B00QCWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/12/2019
• Initial Date FDA Received: 07/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2018
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention