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

Catalog Number CYP

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

Patient Problems Corneal Ulcer (1796); Visual Disturbances (2140)

Event Date 11/01/2012

Event Type  Injury  

Manufacturer Narrative

Suspect product discarded.

Event Description

On (b)(6) 2022, a patient (pt) in brazil reported a corneal ulcer on the left eye (os) while wearing an acuvue® oasys for astigmatism brand contact lens (cl) in (b)(6) 2011.The pt visited an eye care professional (ecp) and was prescribed antibiotics (name and frequency not provided).The pt was unable to provide additional details ¿since this event happened a long time ago.¿ on (b)(6) 2022, a call was placed to the pt¿s treating ecp.A representative advised the pt visited the clinic for a corneal event on (b)(6) 2012 and was discharged from services on (b)(6) 2012.There were no visits on the pt's record for 2011.No additional information was provided.On (b)(6) 2022, the pt called and provided additional information.The pt advised the event date was (b)(6) 2012.The pt advised the os was very sensitive to the light.The pt confirmed that the medication was prescribed every 4 hours for 1 week (name not provided).On (b)(6) 2022, the pt provided additional information via email.The pt confirmed the event dates provided by the ecp are correct ((b)(6) 2012) and advised that the medical report from the ecp has been requested.Multiple attempts have been made to obtain additional medical information from the pt and ecp; nothing has been received.The lot number is unknown.The suspect os cl was discarded.No additional investigation can be conducted.If any further relevant information is received, a supplemental report will be filed.

• Brand Name: ACUVUE® OASYS® FOR ASTIGMATISM
• 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: 15470695
• MDR Text Key: 300444109
• Report Number: 1057985-2022-00074
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P040045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: CYP
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/05/2022
• 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): Required Intervention; Other
• Patient Sex: Female