MAUDE Adverse Event Report: JOHNSON AND JOHNSON ACUVUE BRAND CONTACT LENSES

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Corneal Perforation (1792); Corneal Ulcer (1796)

Event Date 12/08/2016

Event Type  Injury  

Event Description

Patient slept in contact lenses resulting in corneal ulcer that eventually perforated.Required a tectonic penetrating keratoplasty.Diagnosis or reason for use: refractive error.Event abated after use stopped or dose reduced: no.

• Brand Name: ACUVUE BRAND CONTACT LENSES
• Type of Device: ACUVUE BRAND CONTACT LENSES
• Manufacturer (Section D): JOHNSON AND JOHNSON
• MDR Report Key: 6724633
• MDR Text Key: 80542235
• Report Number: MW5071086
• 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: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/17/2017

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: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/17/2017
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 59 YR