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 Problem Bacterial Infection (1735)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On 28oct2019 a patient (pt) in (b)(6) reported a diagnosis of ¿bacteria¿ in the eyes in 2017 while wearing the acuvue® oasys® brand contact lenses.The pt reported wearing the suspect lenses while swimming.The pt advised after the treatment (details not provided), the eye care provider (ecp) recommended daily contact lenses.No additional medical information was provided.On 29oct2019 a call was placed to the pt and additional information was requested.The pt provided an email address and agreed to email contact.No medical information was provided.Multiple attempts were made to the pt for additional medical and product information, but nothing additional has been received.The lot number of the suspect product is unknown.It is unknown if the suspect product is available for return for evaluation.This report is for the left eye (os) event.A separate report will be filed for the right eye (od) event.This os event is being submitted as a worst-case event as we were unable to verify the pts diagnosis and treatment.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: 9342747
• MDR Text Key: 185035207
• Report Number: 1057985-2019-00128
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• Reporter Country Code: BR
• 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: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: PH
• Device Lot Number: UNK-PH
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention