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 Problem Corneal Clouding/Hazing (1878)

Event Date 03/16/2016

Event Type  Injury  

Event Description

The reported information stated the inlay was explanted from the right eye of a (b)(6) male approximately four (4) months postoperatively due to persistent pocket haze.It was also noted that it took three (3) attempts to implant the inlay since the inlay kept folding.This resulted in lengthy manipulation in patient's eye.The patient also underwent a prk procedure on the same day as the kamra inlay implantation.The corneal haze was treated with an extensive steroid regimen: durezol qid along with muro and alphagan to control intraocular pressure.It was reported that the patient's haze has dissipated dramatically and the last bdcva recorded on (b)(6) 2017 was 20/60.

• 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: 6336132
• MDR Text Key: 67593503
• Report Number: 3008401069-2017-00002
• 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
• Report Date: 02/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/27/2017
• Device Model Number: ACI 7000
• Device Catalogue Number: 76043
• Device Lot Number: A556-0515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• 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 (PHOTOREFRACTIVE KERATECTOMY); WAVELIGHT FEMTOSECOND LASER S/N(B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR