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 Corneal Abrasion (1789); Corneal Edema (1791); Corneal Ulcer (1796); Keratitis (1944); Red Eye(s) (2038); Eye Pain (4467)

Event Date 05/01/2023

Event Type  Injury  

Manufacturer Narrative

Suspect product discarded.

Event Description

On 16jan2024 a patient (pt) reported a diagnosis of left eye (os) corneal abrasion ¿about 4 months ago¿ while wearing an acuvue2 brand contact lens (cl).The pt went to an emergency room (date not provided) and a "dye test" showed a corneal abrasion.The pt was prescribed antibiotic drops (name was not provided) 3-4 times daily for 1-2 weeks and a steroid eye drop (name not provided) for another 7 days.The pt was advised not to wear cls.The pt went to an eye care professional (ecp) and was advised to use the steroid eye drops for another 7 days with no cl wear.The pt was unable to wear cls for 3 weeks and reported the os currently remains a "little more sensitive and feels more sore." the pt advised the "corneal abrasion was the worst pain." on 17jan2024 a call was placed to the ecp¿s office for additional medical information.A representative reported the pt was diagnosed with an os corneal edema with an ulcer on 02jun2023 and prescribed tobramycin four times a day (qid) and pred forte qid to "taper off both over 10 days." at the 05jul2023 follow-up visit, the issue was resolved with no scar noted and no permanent damage.The treatment prescribed was considered standard of care.On 17jan2024, a return call was placed to the ecp's office for additional information.The representative advised after further review with the ecp, the ecp did not diagnose a corneal ulcer.The representative reported that the pt went to an urgent care on 28may2023 where the os corneal ulcer was diagnosed.The representative advised the pt was prescribed tobramycin qid.The pt presented to the ecp (optometrist) 2 days later on 30may2023 and the file indicated that the pt had superficial punctate keratitis (spk) in the lower half of the cornea with 2+ edema; the ecp added pred forte qid while continuing tobramycin qid.The pt was reinstructed regarding cl overwear.On 02jun2023, the file indicates the pt had trace injection, no cell or flare, corneal edema ¿much better.¿ no additional medical information was provided.On 18jan2024, a call was placed to the urgent care and a representative advised the pt was seen on 29may2023, not 28may2023, for "possible pink eye." the call was transferred to the er and a representative refused to provide any additional medical information.Additional attempts to contact the pt were conducted on 25jan2024 and 30jan2024, but no additional information has been received.This os corneal ulcer is being reported as a worst-case event as we were unable to verify the diagnosis and treatment with the initial treating facility.The exact date of event is unknown and is being reported as 01may2023.The suspect os cl was discarded.The lot number for the suspect os cl is unknown.No additional investigation can be conducted.If any further relevant information is received, a supplemental report will be filed if applicable.

• 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: 18654991
• MDR Text Key: 334723102
• Report Number: 1057985-2024-00002
• Device Sequence Number: 1
• Product Code: LPM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N18033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: AV2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2024
• 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): Other; Required Intervention
• Patient Age: 38 YR
• Patient Sex: Female