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

Catalog Number PH

Device Problem No Apparent Adverse Event (3189)

Patient Problems Bacterial Infection (1735); Discharge (2225); Excessive Tear Production (2235)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2018, a patient (pt) emailed to report a diagnosis of a bacterial infection while wearing acuvue oasys brand contact lenses (cl).The pt reported that after 48 hours of wearing the cls, the pts eyes water, the cls ¿move a lot¿, and the pts eyes ¿crust¿.The pt reported being diagnosed with a bacterial infection by an optometrist and was prescribed antibiotics (unspecified).The pt reported that the infection would ¿clear¿ but the pt has ¿reoccurring problems¿ when wearing the extended wear cls.Multiple attempts were made to obtain additional information, but were unsuccessful.No additional information was received.The suspect cl availability is unknown.No product or lot information was available.No analysis could be conducted.This report is for the right eye (od) event.A separate report will be filed for the left eye (os) event.If any further relevant information is received, a supplemental report will be filed.Serious reportable event trends are reviewed quarterly in franchise management review meetings.

• 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: 7680974
• MDR Text Key: 113743917
• Report Number: 1057985-2018-00091
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• 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: 06/14/2018
• 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