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

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

Patient Problem Visual Impairment (2138)

Event Date 11/14/2018

Event Type  Injury  

Event Description

The kamra lens inlay was put in my dominant eye and removed a week or so later.A lasik surgery was done in the opposite eye to attempt to rectify the problem of not being able to see.The kamra lens and lasik both ruined my vision.It has been one year and i am still unable to see clearly.I walked into the dr, able to see with a mild eye glass prescription and now i can't see beyond 8 feet.I have been to numerous specialists and this is an ongoing unexplainable unfixable problem and both kamra and lasik should not be fda approved.Fda safety report id # (b)(4).

• Brand Name: KAMRA CORNEAL INLAY
• Type of Device: IMPLANT, CORNEAL, REFRACTIVE
• Manufacturer (Section D): CORNEAGEN, INC.
• MDR Report Key: 9383408
• MDR Text Key: 168285928
• Report Number: MW5091314
• Device Sequence Number: 1
• Product Code: LQE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/25/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 48 YR
• Patient Weight: 49