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 Ulcer (1796); Intraocular Infection (1933); Loss of Vision (2139)
Date of Event	09/21/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
The inlay was explanted 26 days postoperatively from the left eye of a (b)(6) year old female due to reported infection and rejection.Patient is currently taking the following medications to treat the reported condition: ofloxacin, predforte, lotemax, artificial tears, oral acyclovir, bacitracin ointment, and zirgan.
Additional Manufacturer Narrative
Additional information was added to the following other relevant history, describe event or problem, and concomitant medical products.Also, (b)(4) were added.The initial reported was corrected.
Event or Problem Description
Updated information: patient's husband reported on 11/10/2016 that the patient has a corneal ulcer and vision loss associated with a postoperative infection.The patient has since changed physicians.The implanting clinic reported the necrotic corneal tissue in the left eye was debulked and an ambiodisk was placed in the left eye.
Event or Problem Description
The inlay was explanted 26 days postoperatively from the left eye of a (b)(6) female due to reported infection and rejection.Patient was prescribed the following medications to treat the reported condition: ofloxacin, predforte, lotemax, artificial tears, oral acyclovir, bacitracin ointment, and zirgan.The implanting clinic reported the necrotic corneal tissue in the left eye was debulked and an ambiodisk was placed in the left eye.Patient's husband reported on 11/10/2016 that the patient has a corneal ulcer and vision loss associated with a postoperative infection.The patient has since changed physicians.For a detailed sequence of events associated with this patient, please refer to attachment 3.Update: acufocus received an email from the patient on 02/20/2017 stating that she has "permanent eye damage and will need a future cornea transplant." acufocus replied to the patient on 2/22/2017, requesting additional information.To date, no further communication from the patient has been received.

• Brand Name: KAMRA
• Common Device Name: CORNEAL INLAY
• Manufacturer (Section D): ACUFOCUS, INC.; 32 discovery; suite 200; irvine CA 92618
• MDR Report Key: 6049016
• Report Number: 3008401069-2016-00019
• Device Sequence Number: 16233142
• Product Code: LQE
• UDI-Device Identifier: 00813359020007
• UDI-Public: 00813359020007
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/12/2017

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: 07/27/2017
• Device Model Number: ACI 7000
• Device Catalogue Number: 76043
• Device Lot Number: A575-0715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/22/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/21/2016
• Supplement Report FDA Received Date: 12/16/2016; 04/12/2017
• 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: LASIK
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 56 YR