MAUDE Adverse Event Report: JOHNSON & JOHNSON VISION CARE ¿ USA UNK-SOFT CONTACT LENSES; UNK ACUVUE - LENSES- SOFT CONTACT

Catalog Number UNK-SOFT CONTACT LENSES

Device Problem No Apparent Adverse Event (3189)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2018 a patient (pt) reported on social media ¿maybe @acuvue should suggest not sleeping in your contacts since i¿ve had multiple scratches and eye infections in the past year since i switched over.Having a wonderful day off blind and in severe pain.Hospital bound.I think @acuvue should cover the bill¿.No additional information was provided.The event date is unknown.The affected eye is not provided.No patient contact information was provided.The lot number is unknown and it is also unknown if the suspect lens is available for return.This event is being reported as a worst-case event as it was impossible to verify the pts diagnosis and treatment.If additional information is received it will be reported within 30 days of receipt.Serious reportable event trends are reviewed quarterly in franchise management review meetings.

• Brand Name: UNK-SOFT CONTACT LENSES
• Type of Device: UNK ACUVUE - LENSES- SOFT CONTACT
• Manufacturer (Section D): JOHNSON & JOHNSON VISION CARE ¿ USA; 7500 centurion parkway; jacksonville FL
• Manufacturer Contact: rose harrell ; 7500 centurion parkway; jacksonville, FL 32256 ; 9044433374
• MDR Report Key: 7278819
• MDR Text Key: 100411982
• Report Number: 1057985-2018-00019
• Device Sequence Number: 1
• Product Code: LPL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/22/2018
• Initial Date FDA Received: 02/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention