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

Model Number ACI 7000

Device Problem No Apparent Adverse Event (3189)

Patient Problems Corneal Edema (1791); Pain (1994); Visual Impairment (2138); Impaired Healing (2378)

Event Date 09/23/2014

Event Type  Injury  

Event Description

The reported information stated the inlay was explanted from the left eye of male patient approximately 24 days postoperatively due to poor visual acuity (near/far), inflammation, pain, epithelial defect/ingrowth/erosion.

Manufacturer Narrative

The implant, explant, and incident dates were corrected based on additional information.Event description was corrected.Event problem and evaluation codes were updated based on the investigation.

Event Description

One day postoperatively, patient presented with strands of epithelial cells and melting.Twenty (20) days postoperatively the inlay was explanted due to suspected stromal thinning.

• Brand Name: KAMRA
• Type of Device: CORNEAL INLAY
• Manufacturer (Section D): ACUFOCUS, INC.; 32 discovery; suite 200; irvine CA 92618
• Manufacturer (Section G): ACUFOCUS, INC.; 32 discovery; suite 200; irvine CA 92618
• Manufacturer Contact: sandra selvaggi ; 32 discovery; suite 200; irvine, CA 92618 ; 9495859511
• MDR Report Key: 5512237
• MDR Text Key: 40725746
• Report Number: 3008401069-2016-00004
• Device Sequence Number: 1
• Product Code: LQE
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P120023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/27/2014
• Device Model Number: ACI 7000
• Device Catalogue Number: 76125-05
• Device Lot Number: A458-1112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2012
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR