MAUDE MDR 8658108

MDR report key
8658108
Report number
3005357288-2019-00005
Event key
0
Event type
3
Date of event
2019-04-26
Date received
2019-05-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
BENJAMIN STEINBERG
Address
101 N. CHESTNUT ST. STE. 303 WINSTON SALEM NC 27101 US
Phone
336-336-3365
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1KAMRA INLAYKAMRA INLAYCORNEAGENLQE76043A570-0715Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-05-3101. O

Event Narratives#

N

Patient 1

CONVERSATION BETWEEN QA AND DIRECTOR OF MEDICAL AFFAIRS TO DETERMINE REPORTABILITY AND CAUSE. CONCLUSION TO REPORT AND CAUSE LIKELY DUE TO PATIENT MANAGEMENT AND DRY EYE. E-MAIL CHAIN IN REVERSE CHRONOLOGICAL ORDER. "HI (B)(6), CORNEAL NERVES ARE SEVERED DURING POCKET CREATION AND FLAP CREATION IF IT IS A COMBINED PROCEDURE. I THINK DRYNESS MAY BE MORE OF A CULPRIT OF THE SENSATIONS THAN ANYTHING ELSE. THE OTHER FACTOR THAT IS WORTH CONSIDERING IS THAT THE PATIENT IS WHAT WE CALL A 'STEROID RESPONDER' - THAT MEANS THAT THEIR INTRAOCULAR PRESSURE ELEVATES AFTER THEY USE STEROID DROPS - THIS MAY CAUSE SOME SWELLING AND EVEN POSSIBLE HAZE IN THE CORNEA - SO WHATEVER THEY HAD NOTED MAY NOT NECESSARILY HAVE BEEN INLAY RELATED. THERE ARE A LOT OF FACTORS TO CONSIDER HERE OTHER THAN HAZE - I AM WITH YOU IN THAT HAZE MAY HAVE BEEN A BYPRODUCT OF WHAT WAS ORIGINALLY GOING ON AND HOW THE PATIENT WAS MANAGED. HOPE THAT HELPS. (B)(6), O.D. DIRECTOR OF MEDICAL AFFAIRS

D

Patient 1

SURGERY CENTER FIRST REPORTED AS "PATIENT COMPLAINED OF BLURRY VISION, PAIN ETC. HAZE OS FIRST NOTED ON (B)(6) 2018 '2+ HAZE'." FURTHER FOLLOW UP: "THE PATIENT NOTED ON (B)(6) 2019- "VA FLUCTUATION, STINGING, PRESSURE." ON (B)(6) 2019 "PT FEELS SHE STILL GETS HEADACHES". ON (B)(6) 2019- "STILL GETS HEADACHE WITH OS". ON (B)(6) 2018- OS ALWAYS FEELS LIKE FB. PT GETS HEADACHES TO OS BLURRY". ON (B)(6) 2017- COMPLAINS OF SCRATCHY, ITCHY". ON (B)(6) 2016- "FEELS LIKE SOMETHING IS IN EYE, FEELS SCRATCHY/ITCHY". SURGERY WAS ON (B)(6) 2016. THE PATIENT CONSISTENTLY HAD BLURRY VISION IN THE EYE, DESPITE ARTIFICIAL TEARS, DUREZOL, RESTASIS ETC. AND IT LED TO CONSTANT HEADACHES. PATIENT COMPLAINED OF FB SENSATION THRU THE TIME SHE HAD THE INLAY."