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 Conjunctivitis (1784); Corneal Ulcer (1796); Eye Infections (4466); Swelling/ Edema (4577)

Event Date 05/01/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : availability of suspect product unknown.

Event Description

On 01aug2023, an optical store representative called on behalf of a patient (pt) in brazil to report an "issue" with acuvue® oasys® for astigmatism brand contact lenses (cls).The pt visited an eye care professional (ecp) due to an "infection" (date not provided) and was prescribed medication (name, dosage, frequency of use, and affected eye not provided).Multiple attempts were made to contact the pt for additional medical information on 07aug2023, 11aug2023, and 17aug2023 with no success.On 12sep2023, the pt provided a copy of the medical report.Office visit dated (b)(6) 2023: assessment: edema, photophobia, and discharge in the left eye (os) for 1 day biomicroscopy os: small paracentral corneal ulcer at 1 o'clock treatment: zymar and regencel (dosage and frequency of use not provided).On (b)(6) 2023, a call was placed to the pt¿s treating ecp.The medical note provided contains the only information documented on the pt's chart.No additional information is available.Additional attempts were made to contact the pt via phone and email for additional medical information on 13sep2023, 14sep2023, and 19sep2023 with no success.No additional medical information has been received.This event was determined to be serious adverse event on (b)(6) 2023 when the pt's medical report was received and the diagnosis of "paracentral corneal ulcer" was provided.A lot history review was performed and revealed the following: the batch records did not show any abnormalities in monomer and solution testing.All parameters tested were within specification.All sterilization requirements were successfully completed.Lot number b0130hq was produced under normal conditions.Availability of the os suspect cl is unknown.No additional evaluation can be performed.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: 17785581
• MDR Text Key: 323895258
• Report Number: 1057985-2023-00064
• 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,Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: CYP
• Device Lot Number: B0130HQ
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2022
• 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