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

Catalog Number UNK-SOFT CONTACT LENSES

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

Patient Problem Corneal Ulcer (1796)

Event Date 08/02/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, a patient (pt) in argentina left a voice mail message to report a "defective" contact lens (cl).No additional information was provided.On (b)(6) 2023, the pt provided additional information via email.The pt purchased two boxes of contact lenses (acuvue brand not provided), "one month long, through insurance and one came a defective.It ulcerated my eye (affected eye not provided)." no further information was provided.Multiple attempts were made to contact the pt for additional complaint and medical information on 15aug2023, 18aug2023, 22aug2023, 28aug2023 with no success.This corneal ulcer is being reported as a worst-case event as we were unable to verify the diagnosis and treatment with the pt¿s treating eye care professional.The date of the pt¿s event is being recorded as (b)(6) 2023 as the exact event date is unknown.It is unknown what acuvue brand cl was worn at the time of the event.The lot number of the suspect cl is unknown.Availability of the suspect cl is unknown.No additional evaluation can be conducted.If any further, relevant information is received, a supplemental report will be filed.

Manufacturer Narrative

H3 other text : availability of suspect cl unknown.

Manufacturer Narrative

The pt initially reported a lens "ulcerated my eye." mdr # 1057985-2023-00060 was submitted as a worst-case event on 06sep2023 as no additional information was received.On 15sep2023, additional information was received from the patient (pt).The pt reported the term ¿ulcerated my eye¿ meant "discomfort and redness due to a torn lens" in the left eye (os).The pt "always uses the term to describe symptoms in eyes." the pt did not seek medical attention or see a doctor and did not use any medication as "the symptoms resolved." as the pt self-diagnosed and did not seek medical attention, the "corneal ulcer" is no longer considered a serious adverse event.If any further, relevant information is received, a supplemental report will be filed.

• Brand Name: UNK-SOFT CONTACT LENSES
• 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: helene aguilar ; 7500 centurion parkway; jacksonville, FL 32256 ; 9047429918
• MDR Report Key: 17693875
• MDR Text Key: 322773391
• Report Number: 1057985-2023-00060
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: AR
• 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,Followup
• Report Date: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK-SOFT CONTACT LENSES
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2023
• 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): Required Intervention; Other