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

Lot Number A234-0611

Device Problem Material Disintegration (1177)

Patient Problem Visual Impairment (2138)

Event Date 06/11/2018

Event Type  Injury  

Manufacturer Narrative

The lack of visual and dimensional information is attributed to the singapore national eye centre (snec) that the patient went to for the check-up.After explant, the snec histology department took the kamra inlay for analysis.Post analysis the inlay was discarded.Attached as "annex a" is the resulting report for the snec histology department.The patient has suffered some level of hyperopic shift due to the explant; with a slightly melted inlay, removal of some corneal tissue was deemed necessary.The laser used during the aesthetic facial treatment was a nd:yag laser.No safety glasses were worn during the procedure.Details of the laser's pulse, energy, and duration during treatment can be found in annex a.In south korea in early 2014 a similar case was documented by acufocus, inc.As complaint (b)(4).As a result, acufocus issued two field safety notices related to the use of ophthalmic lasers with the kamra inlay implanted.The first in 2014; the second in 2015 with added content on laser based glaucoma therapy.Both field safety notices can be found at the end of this document.In the kamra instructions for use (accessible on the fda website) under section 2.3 potential risks of the kamra inlay there is a subsection indicating risks with use of laser treatments: "laser treatments.There are potential risks of damaging the cornea and/or inlay with the use of some medical lasers with longer wavelengths (650 nm or more) and the lasers in the infrared spectrum are most likely to cause thermal damage to the inlay and surrounding corneal tissue.Thermal scarring has been reported resulting from lasik flap creation with a femtosecond laser and photodynamic therapy.(mita m, et al, 2013) overlapping of the laser beam and the inlay annulus can also result in the release of pigmented carbon granules from the inlay into the corneal tissue." given that a similar case has occurred in the past, two field safety notices were released, and the instructions for use caution the use of lasers near the kamra inlay, this is an incident of known risk.

Event Description

Year five post-kamra operation the patient was noted as being happy with the kamra inlay.However, the patient went to a medical aesthetics clinic to have laser treatment for facial skin tightening and eyelid rejuvenation (non-ablative skin treatment).Post aesthetic laser treatment the patient suffered deteriorating visual acuity and went to the singapore national eye centre for treatment.Damage to the kamra inlay was noted and led to explant on (b)(6) 2018.

• 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: 7935267
• MDR Text Key: 122798388
• Report Number: 3005357288-2018-00004
• Device Sequence Number: 1
• Product Code: LQE
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: P120023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/05/2018,10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/01/2013
• Device Lot Number: A234-0611
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/05/2018
• Device Age: 7 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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