MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional, report with the FDA on 2019-04-05 for KAMRA INLAY manufactured by Corneagen.
[141062652]
Data only goes back as (b)(6) when there was a recentration of the inlay. Corneagen's clinical kamra expert, dr. (b)(6), had details about the case including the following: "i happen to know of this case because i examined this patient. He originally had raindrop and then had kamra implanted. They have a significant history of refractive surgery and corneal manipulation. This was not an ideal candidate for implantation just based on pre-operative history. " it is also noted that the patient had lasik retreat on the same day as the implantation, which is not suggested by corneagen. Given the evidence from the visual acuity and the need for recentration not until nearly 10 months post-implant, and the oils only being found after the recentration, it is not far-fetched to conclude that these negative effects may be due to improper procedures or not following corneagen procedures. This is only supported by the lasik retreat, which is not suggested by corneagen.
Patient Sequence No: 1, Text Type: N, H10
[141062653]
Patient complained of decreased depth perception and worse vision after his reposition on (b)(6) 2019. At examination the it was discovered that the patient's eye had secreted oils on the inlay after his reposition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005357288-2019-00002 |
| MDR Report Key | 8487592 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL, |
| Date Received | 2019-04-05 |
| Date of Report | 2019-04-05 |
| Date of Event | 2019-03-08 |
| Date Mfgr Received | 2019-03-20 |
| Device Manufacturer Date | 2017-03-01 |
| Date Added to Maude | 2019-04-05 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 NC 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 NC 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 INLAY |
| Generic Name | KAMRA INLAY |
| Product Code | LQE |
| Date Received | 2019-04-05 |
| Returned To Mfg | 2019-03-25 |
| Lot Number | A632-0317 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CORNEAGEN |
| Manufacturer Address | 101 N. CHESTNUT ST. STE. 303 WINSTON SALEM NC 27101 US 27101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-05 |