MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE, INC. - US ACUVUE® 2®; LENSES, SOFT CONTACT, EXTENDED WEAR

Catalog Number AV2

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

Patient Problems Eye Injury (1845); Foreign Body Sensation in Eye (1869); Itching Sensation (1943); Red Eye(s) (2038); Loss of Vision (2139); Visual Disturbances (2140); Eye Infections (4466); Eye Pain (4467)

Event Date 12/31/2022

Event Type  Injury  

Manufacturer Narrative

Suspect product discarded.

Event Description

On (b)(6) 2023, a patient (pt) in (b)(6) called to report a ¿laceration¿ in the left eye (os) and is ¿blind.¿ the pt ¿can¿t see well through the eye and has light sensitivity¿.The pt reported wearing the acuvue® 2® brand contact lens (cl) at time the symptoms started on (b)(6) 2022.The pt reported ocular discomfort with the first pair of cls and discarded them after two days of use.The pt didn¿t notice anything unusual with the lenses prior to insertion.The pt went to an eye clinic at a hospital on (b)(6) 2023 after experiencing persisting pain and irritation in the os with a second pair of cls after three days of use.The pt advised the doctor diagnosed the pt with ¿laceration in the retina,¿ redness and itching in the os.The pt was prescribed an antibiotic (unknown name and frequency).The pt reported an ¿eye culture¿ was done as the eye worsened and ¿it got infected¿.The pt remembered the eye culture showed ¿some bacteria¿ and can¿t ¿see through the eye for now.¿ the pt reported a ¿second culture¿ was done, but the pt can¿t recall exact dates.The pt has a follow-up appointment ¿tomorrow¿ to get the results of the second culture os to possibly change treatment.The pt is unable to work or ¿get out of the house¿ as the os is sensitive to light, even at night.The pt uses arlyte solution and replaces the lenses every 20 days.The pt was unable to provide any additional medical information and agreed to request the medical records from the doctor tomorrow and send the records by email for evaluation.Multiple attempts for additional medical information were made to the pt, but nothing additional has been received.A call was placed to the pt¿s treating eye clinic, but the call was not answered.No additional medical information has been received.The os event is being reported as a worst-case as we were unable to verify the pt¿s diagnosis and treatment.The lot number of the suspect os product 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® 2®
• 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: 16395974
• MDR Text Key: 309777640
• Report Number: 1057985-2023-00009
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: AV2
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/23/2023
• 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; Other; Required Intervention
• Patient Sex: Female