MAUDE Adverse Event Report: ACUFOCUS, INC. KAMRA INLAY

Device Problem Insufficient Information (3190)

Patient Problems Corneal Clouding/Hazing (1878); Blurred Vision (2137); Depression (2361)

Event Date 04/26/2016

Event Type  Injury  

Event Description

I have kamra inlay implant on that day by dr.(b)(6), a renown lasik surgeon at (b)(6) laser eye surgery, (b)(6) and since that event my life have been turning upside down.Right after the implant surgery on my right eye, i had blacked out for at least three weeks.After that third week, my vision was blurred 90% of the time and times when it was not blurred it is hazy.My distance vision used to be 20/20 now at three weeks are all ghost visions.Now i am passed four week and a half, my vision are still blurred and hazy 100% percent of the time.I went to an optometrist to get a prescription and that prescription shows that i have a very high astigmatism on my right eye and there was no improvements on my near vision as kamra implant promised.I couldn't read anything at all on the eye chart as all images at distances were all distorted.My surgeon who did the implant remains optimistic that at a given time, i should heal and should see perfectly.He also suggested a repositioning.I went for second opinion at a renown corneal specialist and he suggested to remove the inlay by the same surgeon who did my kamra implant.I told my original surgeon but he seems reluctant.I am depressed with this current situation and i could no longer tolerate this situation as i feel my current implanted eyes have been watery with symptoms like allergy reaction and an eye full of cataracts.What should i do?.

• Brand Name: KAMRA INLAY
• Type of Device: KAMRA INLAY
• Manufacturer (Section D): ACUFOCUS, INC.
• MDR Report Key: 5694339
• MDR Text Key: 46472915
• Report Number: MW5062596
• 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
• Type of Report: Initial
• Report Date: 05/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 52 YR
• Patient Weight: 54