MAUDE Adverse Event Report: ACUFOCUS, INC. KAMRA INLAY; CORNEAL IMPLANT

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Corneal Ulcer (1796); Eye Injury (1845); Intraocular Infection (1933); Pain (1994); Loss of Vision (2139)

Event Date 08/22/2016

Event Type  Injury  

Event Description

I am writing on behalf of my wife.She had kamra inlay surgery on (b)(6) 2016.The trauma caused infections and her doctor removed the inlay.She has a corneal ulcer today and cannot see out of her eye.This should not have occurred and my wife is in great pain with loss of sight that may be permanent.

• Brand Name: KAMRA INLAY
• Type of Device: CORNEAL IMPLANT
• Manufacturer (Section D): ACUFOCUS, INC.
• MDR Report Key: 6102273
• MDR Text Key: 60005799
• Report Number: MW5066027
• Device Sequence Number: 1
• Product Code: LQE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 11/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 61