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

Model Number	ACI 7000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Corneal Abrasion (1789); Corneal Ulcer (1796); Intraocular Infection (1933)
Date of Event	08/29/2016
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: CORNEAL INLAY
• Manufacturer (Section D): ACUFOCUS, INC.; 32 discovery; suite 200; irvine CA 92618
• MDR Report Key: 5984924
• Report Number: 3008401069-2016-00018
• Device Sequence Number: 541965
• Product Code: LQE
• UDI-Device Identifier: 00813359020007
• UDI-Public: 00813359020007
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P120023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/29/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/28/2016
• Supplement Report FDA Received Date: 10/28/2016; 05/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PRK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR