MAUDE Adverse Event Report: KAMRA LENS; IMPLANT, CORNEAL, REFRACTIVE

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

Patient Problem Loss of Vision (2139)

Event Date 11/17/2018

Event Type  Injury  

Event Description

I went to dr (b)(6) in (b)(6) able to see while wearing glasses with a minor prescription.I was tired of wearing glasses.I took his suggestion and had a kamra lens put in the (the incorrect eye), then had lasik in the other eye to attempt to fix vision problems after the kamra was removed.A year later, i cannot see and cannot get glasses to correct my vision.I am unable to see substantial to less, and it has ruined my quality of life.I have revisited tyson numerous times to no avail.I have seen several specialists and there has been no solution thus far.Lasik and kamra should be removed from the market because i am now permanently damaged.Fda safety report id# (b)(4).

• Brand Name: KAMRA LENS
• Type of Device: IMPLANT, CORNEAL, REFRACTIVE
• MDR Report Key: 9342816
• MDR Text Key: 167318988
• Report Number: MW5091175
• Device Sequence Number: 2
• 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: 11/15/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2019
• 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