MAUDE Adverse Event Report: CORNEAGEN KAMRA INLAY

Lot Number A629-1016

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Corneal Clouding/Hazing (1878); Visual Impairment (2138)

Event Date 02/14/2019

Event Type  Injury  

Manufacturer Narrative

The surgeon/surgical team discarded the inlay post explant and did not return it to corneagen quality assurance.It is also important to note that the pocket depth of the implant was 130 micrometers.This is extremely shallow.Implants are supposed to be closer to 250 if not at or approaching 300 micrometers in depth.

Event Description

Patient complained of haze and decreased visual acuity.

• Brand Name: KAMRA INLAY
• Type of Device: KAMRA INLAY
• Manufacturer (Section D): CORNEAGEN; 101 n. chestnut st.; ste. 303; winston salem NC 27101
• Manufacturer (Section G): CORNEAGEN; 101 n. chestnut st.; ste. 303; winston salem NC 27101
• Manufacturer Contact: benjamin steinberg ; 101 n. chestnut st.; ste. 303; winston salem, NC 27101 ; 3365169640
• MDR Report Key: 8483395
• MDR Text Key: 140924702
• Report Number: 3005357288-2019-00001
• Device Sequence Number: 1
• Product Code: LQE
• 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: consumer,health professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/31/2018
• Device Lot Number: A629-1016
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2016
• 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: 49 YR