FDA.reportPublic FDA data

MAUDE MDR 9785929

MDR report key
9785929
Report number
MW5093503
Event key
0
Event type
3
Date of event
2020-02-26
Date received
2020-03-03
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 PRODUCTSALCONLPN Y
101---

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-0301. H

Event Narratives#

D

Patient 1

CLEAR CARE CONTACT LENS SOLUTION BURNED MY EYE. WHEN MY EYE WAS BURNING, I TRIED TO FLUSH IT WITH MORE OF THE SOLUTION, BECAUSE I NEVER THOUGHT THAT A CONTACT LENS SOLUTION WOULD BURN MY EYE. I WAS UNABLE TO READ THE LABEL WHILE MY EYE WAS BURNING. THE LABEL ON THE BOX AND THE BOTTLE IS INADEQUATE. I WENT TO AN EYE HOSP AND HAD TO TAKE 2 MEDS. MY EYE IS STILL NOT NORMAL AFTER 4.5 DAYS.