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 08/07/2018

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 incident is entirely due to the kamra inlay.The surgeon performed a secondary procedure to correct a misaligned inlay, and then problems continued to persist prompting the explant.Continuous symptoms from prior to the recentration indicate the ucva scores may be attributed to a second centration issue.

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 until the inlay was explanted.

• 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 NC 27101
• Manufacturer Contact: benjamin steinberg ; 101 n. chestnut st.; ste. 303; winston salem, NC 27101 ; 3365169640
• MDR Report Key: 7962284
• MDR Text Key: 123669388
• Report Number: 3005357288-2018-00006
• 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: No Information
• Device Expiration Date: 03/01/2020
• Device Lot Number: A633-0317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2018
• Was Device Evaluated by Manufacturer?: 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: 58 YR