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 Bacterial Infection (1735); Corneal Scar (1793)

Event Date 01/01/2009

Event Type  Injury  

Manufacturer Narrative

H3 other text : suspect product availability is unknown.

Event Description

On 27sep2023, an email was received with notification of mw123258 after conducting a maude database search on the fda website.A patient (pt) was diagnosed with a pseudomonas infection in the right eye (od) in 2009, while wearing a spherical acuvue® oasys® brand contact lens (cl).The pt advised the infection was ¿cured within 4 months and i used may be a one litre of eyedrops.¿ the pt reported ¿after healing due to cornea deformation is now sph.-s cyl ?1,25@ axis so or 60 degrees a little white scar has shown in my cornea.¿ no additional medical information was provided related to the 2009 od event.No pt contact information is available.No additional medical information is expected.The date of the event is unknown and will be reported as (b)(6) 2009.The suspect lot number was not provided.No additional evaluation can be conducted.It is unknown if the suspect od cl is available for return for evaluation.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

On 20nov2023, it was noted in a file review that the medwatch number was incorrectly submitted to the fda on 17oct2023 in the initial mdr 1057985-2023-00077.On 17oct2023, the initial mdr 1057985-2023-00077 was incorrectly noted as ¿mw123258.¿ the correct medwatch number is ¿mw5123258.¿ if any further relevant information is received, a supplemental report will be filed as appropriate.

• 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 32256
• Manufacturer Contact: helene aguilar ; 7500 centurion parkway; jacksonville, FL 32256 ; 9047429918
• MDR Report Key: 17953467
• MDR Text Key: 325898713
• Report Number: 1057985-2023-00077
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: PH
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Required Intervention; Other