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 Clouding/Hazing (1878); Intraocular Infection (1933); Impaired Healing (2378)
Date of Event	08/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device potentially contaminated with (b)(6).
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: CORNEAL INLAY
• Manufacturer (Section D): ACUFOCUS, INC.; 32 discovery; suite 200; irvine CA 92618
• MDR Report Key: 5975497
• Report Number: 3008401069-2016-00017
• Device Sequence Number: 958148
• 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: other,user facility
• 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: 09/23/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR