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 Edema (1791); Corneal Ulcer (1796); Corneal Clouding/Hazing (1878); Corneal Infiltrates (2231)

Event Date 01/29/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On october 09, 2015, acufocus, inc.Became aware of an inlay being explanted approximately four (4) months postoperatively due to an inflammatory reaction which manifested as haze, infiltrates, and reduced visual acuity (va).The inflammation was noted to reoccur as soon as pred forte eye drops were discontinued.One (1) day following the removal of the inlay, on (b)(6) 2014, the patient was referred to the (b)(6) hospital, and was diagnosed with left eye post operative microbial keratitis.The aforementioned hospital prescribed vancomycin, ceftazidine, cyclopentolate, and pred.Minims.

Manufacturer Narrative

Patient codes were corrected to reflect infiltrate and corneal ulcer based on the results of the investigation.

• 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: 5210069
• MDR Text Key: 30682640
• Report Number: 3008401069-2015-00009
• 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: Initial,Followup
• Report Date: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2014
• Device Model Number: ACI 7000
• Device Catalogue Number: 76125-05
• Device Lot Number: A424-0912
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2012
• 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: 54 YR