MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-10-04 for KAMRA CORNEAL INLAY manufactured by Corneagen.
[122798388]
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.
Patient Sequence No: 1, Text Type: N, H10
[122798389]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005357288-2018-00004 |
| MDR Report Key | 7935267 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-10-04 |
| Date of Report | 2018-10-03 |
| Date of Event | 2018-06-11 |
| Date Facility Aware | 2018-09-05 |
| Report Date | 2018-09-05 |
| Date Reported to Mfgr | 2018-09-05 |
| Date Added to Maude | 2018-10-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BENJAMIN STEINBERG |
| Manufacturer Street | 101 N. CHESTNUT ST. STE. 303 |
| Manufacturer City | WINSTON SALEM 27101 |
| Manufacturer Country | US |
| Manufacturer Postal | 27101 |
| Manufacturer Phone | 3365169640 |
| Manufacturer G1 | CORNEAGEN |
| Manufacturer Street | 101 N. CHESTNUT ST. STE. 303 |
| Manufacturer City | WINSTON SALEM 27101 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KAMRA CORNEAL INLAY |
| Generic Name | KAMRA INLAY |
| Product Code | LQE |
| Date Received | 2018-10-04 |
| Lot Number | A234-0611 |
| Device Expiration Date | 2013-06-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 7 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CORNEAGEN |
| Manufacturer Address | 101 N. CHESTNUT ST. STE. 303 WINSTON SALEM 27101 US 27101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-04 |