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

Device Problem Insufficient Information (3190)

Patient Problems Corneal Edema (1791); Blurred Vision (2137)

Event Date 09/14/2015

Event Type  Injury  

Manufacturer Narrative

Actual device remains implanted in the patient's eye and was not evaluated.The instructions for use for the kamra inlay, involving both the united states (us) and outside the united states (ous) product labeling (ifu p/n's 61017 and 61016-05, respectively), contain statements warning against the creation of a femtosecond laser flap with the kamra inlay in place.The doctor involved in this event was informed of this warning and signed an acknowledgement on (b)(6) 2014 which is on file at acufocus, inc.Device remains implanted in the patient.

Event Description

On (b)(6) 2015, the doctor reported he cut a femtosecond (f/s) flap on a patient that had a kamra inlay implanted.The doctor reported the inlay turned greyish, cornea is not clear, inlay is depressed in the stroma, and corneal edema is present.An aggressive steroid regimen of tobrason and hylokomod was initiated on (b)(6) 2015.

• Brand Name: KAMRA
• Type of Device: CORNEAL INLAY
• Manufacturer (Section D): ACUFOCUS, INC.; 32 discovery; suite 200; irvine CA 92618
• Manufacturer (Section G): ACUFOCUS, INC.; 32 discovery; suite 200; irvine CA 92618
• Manufacturer Contact: sandra selvaggi ; 32 discovery; suite 200; irvine, CA 92618 ; 9495859511
• MDR Report Key: 5152949
• MDR Text Key: 28368731
• Report Number: 3008401069-2015-00003
• Device Sequence Number: 1
• Product Code: LQE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 10/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR