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 Problems Corneal Ulcer (1796); Dry Eye(s) (1814)

Event Date 01/01/2005

Event Type  Injury  

Manufacturer Narrative

Unknown suspect product availability.

Event Description

On 04mar2024, a johnson and johnson employee reported that a patient (pt) posted a complaint on a social media website.The pt reported, ¿i wore acuvue since 2005 until 2019.I had a lot of ulcers on my retina from dry eyes.I was told acevue is the worst and cheapest made contact.Switch and haven't had an ulcer since." no additional information was provided.No further medical or product information has been received after multiple attempts were made for additional information.This event is being reported as worst-case as we were unable to verify the pt's diagnosis and treatment.As it is unknown which acuvue brand contact lens was worn at the time of the event, the product will be reported as an unknown acuvue brand contact lens.The event date is being reported as 01jan2005 as the exact date of the event is unknown.The affected eye is unknown.The lot number of the suspect product is unknown.It is unknown if the suspect product is available for evaluation.No additional evaluation can be conducted.If any further relevant information is received, a supplemental report will be filed if applicable.

• 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: 19007047
• MDR Text Key: 338981065
• Report Number: 1057985-2024-00012
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• 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: 03/04/2024
• 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): Required Intervention; Other