MAUDE Adverse Event Report: CORNEAGEN KAMRA CORNEAL INLAY; KAMRA INLAY

Lot Number A633-0317

Device Problem Use of Device Problem (1670)

Patient Problem Visual Impairment (2138)

Event Date 08/28/2018

Event Type  Injury  

Manufacturer Narrative

After visually inspecting the inlay and reviewing the dhr, visual acuity table, and circumstantial information about the case this incident is reportable to the fda.However, it is not possible to definitively say that the slow recovery time and ucva scores are due to the kamra inlay.The surgeon performed a secondary procedure involving a laser--a decision that is strongly cautioned against in the kamra inlay ifu--within a 24 hour period of re-centering a new inlay.

Event Description

The patient had an initial inlay implanted.The doctor deemed it was off center and required recentration with another kamra inlay.The recentration was not effective and lead to continued visual problems with the patient.This lead to a permanent of explant of the inlay.It is noted that in this case, the patient was slow to recover.Also noted is that the patient went through topographic guided lasik/t-cat surgery within the same 24 hours; a process advised against in the ifu of kamra inlays.

• Brand Name: KAMRA CORNEAL INLAY
• Type of Device: KAMRA INLAY
• Manufacturer (Section D): CORNEAGEN; 101 n. chestnut st.; ste. 303; winston salem 27101
• Manufacturer (Section G): CORNEAGEN; 101 n. chestnut st.; ste. 303; winston salem 27101
• Manufacturer Contact: benjamin steinberg ; 101 n. chestnut st.; ste. 303; winston salem 27101 ; 3365169640
• MDR Report Key: 7961796
• MDR Text Key: 123570675
• Report Number: 3005357288-2018-00005
• 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: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: A633-0317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Device Age: 17 MO
• Date Manufacturer Received: 09/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• 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