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

Catalog Number UNK-SOFT CONTACT LENSES

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

Patient Problems Bacterial Infection (1735); Corneal Ulcer (1796); Fungal Infection (2419); Eye Pain (4467)

Event Date 08/28/2021

Event Type  Injury  

Manufacturer Narrative

Unknown product availability.

Event Description

On 24oct2021 during a routine review of the fda maude database, voluntary medwatch report # mw5104266 was discovered. The initial reporter advised that a patient (pt) was diagnosed with ¿fungal keratitis due to sleeping in contact lenses. ¿ the date of the event is reported as (b)(6) 2021. ¿patient problems: pain. ¿ it is unknown which eye was the affected eye. No contact name or information was provided. No additional information can be obtained. It is unknown what acuvue daily contact lens brand was worn at the time of the event. The lot number of the suspect product was not provided. It is unknown if the suspect product is available for return for evaluation. No additional evaluation can be conducted. If any further relevant information is received, a supplemental report will be filed.

• Brand Name: UNK-SOFT CONTACT LENSES
• Type of Device: UNK-SOFT CONTACT LENSES
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE, INC. - US; 7500 centurion parkway; jacksonville FL 32256
• Manufacturer Contact: richard holmes ; 7500 centurion parkway; jacksonville, FL 32256 ; 9548020487
• MDR Report Key: 12790186
• MDR Text Key: 280810537
• Report Number: 1057985-2021-00172
• 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: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK-SOFT CONTACT LENSES
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/07/2022
• 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 Treatment Data

Date Received: 11/10/2021 Patient Sequence Number: 1