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 Clouding/Hazing (1878); Intraocular Infection (1933); Impaired Healing (2378)

Event Date 08/29/2016

Event Type  Injury  

Manufacturer Narrative

Device potentially contaminated with (b)(6).

Event Description

The reported information stated the inlay was explanted from the right eye of a (b)(6) year old female patient approximately one month and twenty days postoperatively due to an infection.

Manufacturer Narrative

This correction is required as some patient details between this event and the event (b)(6)/mdr 3008401069-2016-00018 were comingled.Additional verification of the information was required and was performed on (b)(6) 2016 via onsite visit at the beach eye care facility.

Event Description

The reported information stated the inlay was explanted from the left eye of a (b)(4) year old female patient approximately one (1) month and twenty-one days postoperatively due to corneal haze, epithelial defect, and corneal abrasion.Central haze was initially noted following the prk procedure performed on (b)(6) 2016.As a result, a bandage contact lens (bcl) was placed.Despite the presence of haze, the kamra inlay was implanted approximately one (1) month later on (b)(6) 2016.One day later on (b)(6) 2016, a central abrasion was noted.The central abrasion was healed on (b)(6) 2016; however, another paracentral abrasion was noted on (b)(6) 2016.The kamra inlay was explanted on (b)(6) 2016.Following explantation of the kamra inlay the patient was reported to have a corneal ulcer.

• 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: 5975497
• MDR Text Key: 55562154
• Report Number: 3008401069-2016-00017
• 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: other,user facility
• 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: 09/23/2016
• 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: 11/17/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR