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

Model Number ACI 7000

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

Patient Problems Corneal Abrasion (1789); Corneal Ulcer (1796); Intraocular Infection (1933)

Event Date 08/29/2016

Event Type  Injury  

Event Description

The reported information stated the inlay was explanted for a (b)(6) year old female patient approximately 24 days postoperatively due to an infection, abrasion, and haze over the inlay.

Manufacturer Narrative

The correction is required as some patient details between this event and the event (b)(4)/mdr3008401069-2016-00017 were comingled.Additional verification of the information was required and was performed on 12/13/2016 via onsite visit at the (b)(6) eye care facility.

Event Description

The reported information stated the inlay was explanted from the right eye of a (b)(6) female patient approximately 24 days postoperatively due to infection/keratitis, haze and an abrasion over the inlay.A corneal abrasion was initially noted 11 days postoperatively coupled with the patient's history of cold sores.It was attributed to a (b)(6) infection and treated with (b)(6).Following explantation of the kamra corneal inlay, the abrasion progressed to a (b)(6) ulceration with hypopon.The cornea was debulked, vancomycin and tobradex were prescribed to treat the ulceration along with an increase in the acyclovir dosage.As of (b)(6) 2016, it was reported that the patient's ulcer is 50% smaller and the patient is doing better.

• Brand Name: KAMRA
• Type of Device: CORNEAL INLAY
• Manufacturer (Section D): ACUFOCUS, INC.; 32 discovery; suite 200; irvine CA 92618
• Manufacturer Contact: sandra selvaggi ; 32 discovery; suite 200; irvine, CA 92618 ; 9495859511
• MDR Report Key: 5984924
• MDR Text Key: 55873025
• Report Number: 3008401069-2016-00018
• Device Sequence Number: 1
• Product Code: LQE
• UDI-Device Identifier: 00813359020007
• UDI-Public: 00813359020007
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2017
• Device Model Number: ACI 7000
• Device Catalogue Number: 76043
• Device Lot Number: A553-0415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2015
• 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
• Treatment: PRK
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR