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 Abscess (1690); Bacterial Infection (1735); Burning Sensation (2146); Discomfort (2330)

Event Date 11/14/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Initial reporter¿s phone number: (b)(6).

Event Description

On 21nov2019 a call was received from a patient¿s (pt) family member in argentina who reported the pt had an ¿eye bacteria¿ (affected eye not provided) caused by the acuvue® oasys® brand contact lens.The pt went to the emergency room yesterday, (b)(6) 2019.No additional information was provided.On 21nov2019 additional information was provided: the pt wanted provide information as the ¿lens produced abscess¿ in the eye.On 21nov2019 a call was placed to the pt who provided additional information: the pt reported od discomfort and burning sensation on (b)(6) 2019 which continued after removing the suspect lens.The pt went to an urgent care and then was transferred to another eye center due to ¿severity of eye.¿ the diagnosis was not provided.The pt was prescribed vigamox eye drops every 2 hours, eritromed (erythromycin) eye drops every 2 hours for 1 week and artelac (lubricating eye drops) for dryness as needed.The pt had a follow-up visit on (b)(6) 2019 and the medications were changed to vigamox tid for 7 days and lopred tid for 7 days.The pt stated after the 7 days of tid eye drops, the eye drops of vigamox and lopred were decreased to bid for 7 days.The pt has a return visit with the eye care provider (ecp) scheduled for (b)(6) 2019.The pt reported the od is feeling better.The pt has a 2-week replacement schedule with daily lens wear.The pt uses opti-free pure moist solution and arlyt solution to clean and store the lenses.The pt¿s medical records were requested.The pt will pick up the medical records from the ecp on (b)(6) 2019 and will send the records by email.Multiple calls were placed to the pt for additional medical information, but nothing additional has been received.Multiple calls were placed to the pts treating ecp for additional medical information.Nothing additional has been provided.This od event is being reported as a worst-case event as we were unable to verify the pts diagnosis and treatment with the treating ecp.The suspect od contact lens was requested for return for evaluation, but it has not been received.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 b00s8j2 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: 9454240
• MDR Text Key: 185043708
• Report Number: 1057985-2019-00142
• 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: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2024
• Device Catalogue Number: PH
• Device Lot Number: B00S8J2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 34