FDA.reportPublic FDA data

MAUDE MDR 9853254

MDR report key
9853254
Report number
MW5093833
Event key
0
Event type
3
Date of event
2020-03-16
Date received
2020-03-18
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 CAREACCESSORIES, SOFT LENS PRODUCTSALCON RESEARCH, LLCLPNI Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-180

Event Narratives#

D

Patient 1

THIS PRODUCT SHOULD NOT BE IN AISLES WITH OTHER NORMAL CONTACT SOLUTIONS. RINSED MY CONTACT LENSE IN CLEAR CARE CONTACT LENSE SOLUTION AND EXPERIENCED BURNING, STINGING AND EYE REDNESS. IT BURNED SO BAD I COULDN'T TAKE THE CONTACT OUT. DID THE PROBLEM STOP AFTER THE PERSON REDUCED OR STOPPED USING THE PRODUCT? NO. FREQUENCY: DAILY. HOW WAS IT TAKEN OR USED: OPHTHALMIC. REASON FOR USE: TO CLEAN CONTACTS.