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

Catalog Number AAS

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

Patient Problems Corneal Scar (1793); Red Eye(s) (2038)

Event Date 09/01/2021

Event Type  Injury  

Event Description

On 18oct2021 an email received from a distributor advised an eye care provider (ecp) in (b)(6) reported a patient (pt) was diagnosed with redness and corneal opacities while wearing the acuvue® vita¿ for astigmatism brand contact lenses (cls).On 26oct2021 the reporting ecp provided additional medical information.The event occurred in (b)(6) 2021.The pt reported redness after using the lenses for 3 to 4 hours ou.After 4 days both eyes were still red.The ecp diagnosed the pt with corneal opacities in od and the os and the pt was referred to an ophthalmologist.The treatment is unknown.The ophthalmologist advised the pt not to use the lenses as a ¿resolution¿ and after 15 days, the pts eyes were fine.The ecp advised the ophthalmologist refused to share any additional details.No additional medical information was provided.No additional medical information is expected.A lot history review was performed and revealed the following: the batch record did not show any abnormalities in monomer and solution testing.All parameters tested were within specification.All sterilization requirements were successfully completed.Lot b00nxhm was produced under normal conditions.This report is being submitted for the pts os event.The event for the pts od will be submitted in a separate report.The suspect os cls was discarded.No additional evaluation can be conducted.If any further relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

Suspect product discarded.

• Brand Name: ACUVUE® VITA¿ FOR ASTIGMATISM
• Type of Device: LENSES, SOFT CONTACT, DAILY WEAR
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. - US; 7500 centurion parkway; jacksonville FL 32256
• Manufacturer Contact: richard holmes ; 7500 centurion parkway; jacksonville, FL 32256 ; 9548020487
• MDR Report Key: 12782833
• MDR Text Key: 282126096
• Report Number: 1057985-2021-00170
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K160212
• 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: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/01/2022
• Device Catalogue Number: AAS
• Device Lot Number: B00NXHM
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/21/2017
• 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