MAUDE MDR 5808306

MDR report key
5808306
Report number
MW5063510
Event key
0
Event type
3
Date of event
2015-07-28
Date received
2016-07-16
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GOLDMANN APPLANATION TONOMETRYGOLDMANN APPLANATION TONOMETRYS4 OPTIK LLCHKY* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-07-1601. O; 2. S

Event Narratives#

D

Patient 1

MY EYES WERE HEALTHY BEFORE (B)(6) 2015. I WENT TO (B)(6) FOR VISION TESTING, SO I CAN BUY A NEW PAIR OF EYEGLASSES. I WAS ATTENDED BY AN EXCHANGE STUDENT FROM (B)(4). SHE WAS VERY INEXPERIENCED. SHE DID THE CONTACT TYPE GOLDMANN APPLANATION TONOMETRY ON ME ASKING ME NOT TO MOVE MY EYE BUT PRESSING THE DEVICE HARD AGAINST MY EYES. THE CLINICAL SUMMARY SHOWED THAT THERE ARE MILD ARC STAIN MARK OF TONOMETRY, I. E., SHOWING DAMAGE DONE TO MY CORNEA. SHE THEN DID EYELID EVERSION AND TOUCHED THE EYELID OF MY LEFT EYE WITH THE TIP OF A COTTON APPLICATOR. I SWAYED MY HEAD AS IT WAS UNANNOUNCED TOUCHING. THE TIP SCRATCHING MY LEFT CORNEA OR CONJUNCTIVE. THEN, SHE INSTILLED MYDRIN-P (SANTEN, (B)(4)) ONE DROP ON EACH OF MY EYES FOR DILATORY FUNDUS EXAM. MYDRIN-P CONTAINED 0.5% OF PHENYLEPHRINE WHICH WAS FOUND CYTOTOXIC IN A RECENT STUDY BY (B)(6), ET AL 2016 (ACTUALLY ITS CYTOTOXIC PROPERTIES WAS FOUND AS EARLY AS IN 1979). AS A RESULT, MY CORNEAL EPITHELIAL NOCICEPTORS/SUB-EPITHELIAL NERVE PLEXUS WAS ALTERED CAUSING SPONTANEOUS PAIN EVERYDAY AND LOSS OF CORNEAL EQUILIBRIUM, PERSISTENTLY INFLAMED CONJUNCTIVE AND LACRIMAL CARUNCLE - THE EYE CONDITION IS CALLED OPHTHALMODYNIA (WITH REDUCTION OF TEAR PRODUCTION).