MAUDE MDR 9677095

MDR report key
9677095
Report number
MW5092818
Event key
0
Event type
3
Date of event
2019-01-01
Date received
2020-02-05
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
1HYDROGEN PEROXIDE CLEANING SOLUTIONACCESSORIES, SOFT LENS PRODUCTSUNKLPN* *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-050

Event Narratives#

D

Patient 1

I AM GOING ON VACATION TO THE BEACH FOR CHRISTMAS AND HAVE TO BUY MY USUAL SALINE SOLUTION. I BRING BOTH BOTTLES UP TO THE PHARMACIST TO ASK IF THEY'RE THE SAME OR JUST A DIFFERENCE IN PRICE? SHE ASSURES ME THEY ARE THE EXACT SAME THING. SHE READS THE INGREDIENTS AND SAYS YEAH THEY WORK THE SAME AND EVEN OPENS THE BOX AND SEES A WEIRD CONTACT LENSES CASE AND SAYS SHE'S NEVER SEEN THAT BEFORE BUT STILL FIRMLY SAYS IT'S THE SAME THING. I GO HOME AND DON'T REALLY UNDERSTAND SO I LET THEM SOAK AND DO THE MISTAKE OF PUTTING THEM IN MY EYE. THE PAIN BURNED SO MUCH LIKE ACID IN MY EYE THAT MY EYE INVOLUNTARILY CLOSED SHUT AND I HAD TO PRY MY EYE OPEN TO GET IT OUT. IT'S BEEN CLOSE TO 48 HOURS AND I STILL FEEL LIKE SOMETHING IS IN MY EYE AND MY EYE IS STILL COMPLETELY RED. WHEN AND HOW WAS ERROR DISCOVERED: AT HOME. THE PHARMACIST TOLD ME FIRMLY SAYING IT IS THE SAME, AND AS A RESULT I BURNED MY EYE. WITHOUT INSURANCE I AM STUCK DEALING WITH A BURNING RED EYE AND CLOSE TO 48 HOURS NO MAJOR IMPROVEMENTS. (B)(6), ACCESS NUMBER: (B)(4).