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 Code	Dry Eye(s) (1814)
Date of Event	04/22/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
The reported information stated that the inlay was explanted from the left eye of a (b)(6) year old male patient approximately eight (8) months postoperatively due to poor corneal healing caused by persistent dry eye.It was noted that the patient had difficulty complying with the post-operative regimen.
Event or Problem Description
Updated information: the patient was last seen in the clinic on (b)(6) 2016.At this time, the patient's near visual acuity was 20/50 and distance visual acuity was 20/40.Patient reported improved vision.The slit lamp exam revealed only mild haze.On same day as the visit, (b)(6) 2016 the patient had a lasik enhancement.Patient has discontinued use of pred forte.

• Brand Name: KAMRA
• Common Device Name: CORNEAL INLAY
• Manufacturer (Section D): ACUFOCUS, INC.; 32 discovery; suite 200; irvine CA 92618
• MDR Report Key: 5717249
• Report Number: 3008401069-2016-00010
• Device Sequence Number: 522557
• Product Code: LQE
• UDI-Device Identifier: 00813359020007
• UDI-Public: 00813359020007
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P120023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/27/2017
• Device Model Number: ACI 7000
• Device Catalogue Number: 76043
• Device Lot Number: A548-0315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/16/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/10/2016
• Supplement Report FDA Received Date: 10/14/2016; 12/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Weight: 88