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

Model Number ACI 7000

Device Problem Insufficient Information (3190)

Patient Problem Blurred Vision (2137)

Event Date 11/07/2016

Event Type  Injury  

Manufacturer Narrative

An attempt to retrieve the lot number from the reporter was performed.However, the reporter stated that they did not record the lot number; therefore the lot number associated with this event cannot be retrieved.

Event Description

The reported information stated the inlay was explanted from the left eye of a (b)(6) female patient approximately five (5) months postoperatively due to blurred vision.

Event Description

Updated information: patient was last seen on (b)(6) 2016.At this time her ucdva was reported to be 20/70 with a 1+ haze in the pocket and 2+ spk.The patient will discontinue prednisolone and return to the clinic in one (1) month.

• Brand Name: KAMRA
• Type of Device: CORNEAL INLAY
• Manufacturer (Section D): ACUFOCUS, INC.; 32 discovery; suite 200; irvine CA 92618
• Manufacturer Contact: sandra selvaggi ; 32 discovery; suite 200; irvine, CA 92618 ; 9495859511
• MDR Report Key: 6152350
• MDR Text Key: 61650321
• Report Number: 3008401069-2016-00021
• Device Sequence Number: 1
• Product Code: LQE
• UDI-Device Identifier: 00813359020007
• UDI-Public: 00813359020007
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ACI 7000
• Device Catalogue Number: 76043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 47 YR