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

Catalog Number ATL

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

Patient Problems Bacterial Infection (1735); Corneal Scar (1793); Corneal Ulcer (1796); Red Eye(s) (2038); Eye Pain (4467)

Event Date 03/01/2021

Event Type  Injury  

Manufacturer Narrative

Suspect product was discarded.

Event Description

On (b)(6) 2021 a patient (pt) called to report a diagnosis of os corneal ulcer while wearing the acuvue® vita¿ brand contact lens (cls).The pt reported the lenses were purchased (b)(6) 2021 and thinks the initial visit to the eye care provider (ecp) was near the end of (b)(6) or beginning of (b)(6) 2021.The pt reported weekly visits with the ecp until the last visit today, (b)(6) 2021.The ecp thought it was a ¿bacterial infection¿ and advised the pt today ((b)(6) 2021) that the corneal ulcer looks healed but has scarring from ¿where the infection was.¿ the location of the os corneal ulcer is unknown.The ecp advised the pt to use rewetting drops and continue with no cls wear.The pt also had an amniotic membrane procedure (date not provided) on the eye.The ecp prescribed besivance q2h while awake for 1 week, then return for a follow-up (fu) appointment.At the fu appointment (date not provided), the pt was instructed to discontinue besivance and use neomycin/polymyxcin b/dexamethasone eye drops q4h until the next fu appointment.At the next fu appointment (date not provided), the pt was instructed to resume besivance q2h while awake.The pt reported using besivance on and off during the entire treatment, 2 or 3 bottles.The pt reports daily cls wear and uses optifree puremoist solution.The pt woke with redness and pain (date was not provided), did not wear the lenses that day, then went to the ecp for evaluation.The suspect os cls was worn for 2 days, then discarded.No additional medical information was provided.Multiple attempts were placed to the pts treating ecp to verify the pt¿s diagnosis and treatment, but nothing additional has been received.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 b00x7987 was produced under normal conditions.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.

• Brand Name: ACUVUE VITA
• 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: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433647
• MDR Report Key: 11962325
• MDR Text Key: 263487532
• Report Number: 1057985-2021-00136
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: ATL
• Device Lot Number: B00X7987
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/18/2021
• Initial Date FDA Received: 06/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2021
• 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): Other; Required Intervention
• Patient Age: 31 YR