MAUDE MDR 7078889

MDR report key
7078889
Report number
MW5073700
Event key
0
Event type
3
Date of event
2017-11-29
Date received
2017-12-01
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
1CLEAR CARE CONTACT SOLUTION PLUSSOFT (HYDROPHILIC) CONTACT LENS CARE PRODUCTSALCONLRXI N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-12-010

Event Narratives#

D

Patient 1

I USED CLEAR CARE CONTACT CLEANING SOLUTION. I DID NOT PUT IT IN THE CONTACT CASE THAT WAS PROVIDED BECAUSE MINE HAD GOT BROKE WHILE TRAVELING, SO I PUT IT IN A NORMAL CONTACT CASE ALONG WITH MY CONTACTS. MY CONTACTS WAS IN THE SOLUTION FOR 2 DAYS BECAUSE I WORE MY GLASSES. WHEN I PUT MY CONTACT IN, I EXPERIENCED EXTREME BURNING AND STINGING. I IMMEDIATELY RINSED MY EYE WITH COLD WATER FOR SEVERAL MINUTES. IT HAS BEEN NEARLY 2 HRS SINCE THE INCIDENT AND MY EYE IS NOW SWOLLEN, RED AND BURNING. THIS CONTACT SOLUTION SHOULD BE TAKEN OFF THE SHELVES. THERE ARE WAY TO MANY RISKS OF USING THE PRODUCT. "IS THE PRODUCT OVER-THE-COUNTER: YES." QUANTITY: 1 DROP(S), FREQUENCY AS NEEDED. "HOW WAS IT TAKEN OR USED: EYE CONTACT." "DID THE PROBLEM STOP AFTER THE PERSON REDUCED THE DOSE OR STOPPED TAKING OR USING THE PRODUCT: YES, DID THE PROBLEM RETURN IF THE PERSON STARTED TAKING OR USING THE PRODUCT AGAIN: DOESN'T APPLY." REASON FOR USE: TO CLEAN CONTACTS.