MAUDE MDR 7918608

MDR report key
7918608
Report number
MW5080183
Event key
0
Event type
3
Date of event
2018-09-11
Date received
2018-09-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
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
0BAUSCH AND LOMB ADVANCED EYE RELIEF EYE WASH EYE IRRIGATING SOLUTIONACCESSORIES, SOLUTION, ULTRASONIC CLEANERSBAUSCH AND LOMB, INC.LYLGH17027 OR GH17017I Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-09-2701. O

Event Narratives#

D

Patient 1

PT CAME IN FOR A F/U APPT ON (B)(6) 2018. PT STRONG CONTACT LENSES IN CLINIC EYE WASH SOLUTION (BAUSCH+LOMB ADVANCED EYE RELIEF EYE WASH EYE IRRIGATING SOLUTION LOT #GH17017 6319814 WITH EXP 08/2019). INGREDIENTS LISTED AS: 99.05% PURIFIED WATER, BORIC ACID, SODIUM BORATE AND SODIUM CHLORIDE, AND BENZALKONIUM CHLORIDE 0.01%. THE PT PUT ON HER CONTACT LENSES AFTER STORING THEM IN THIS SOLUTION AND LEFT THE HOSPITAL. HER EYES BEGAN TO FEEL UNCOMFORTABLE AFTER LEAVING THE HOSPITAL, SO SHE TOOK OUT HER CONTACTS AND STARTED RINSING HER EYES. SHE WAS NOT FEELING BETTER, SO SHE WAS DRIVEN BACK TO THE HOSP BY HER HUSBAND AND WAS SEEN AT 3:30PM. PROPARACAINE WAS INSTILLED FOR PT COMFORT AND REFRESH ARTIFICIAL TEARS WERE INSTILLED EVERY 10 MINS. WE PRESCRIBED REFRESH NON-PRESERVED ARTIFICIAL TEARS EVERY 15 MINS IN BOTH EYES AND TO F/U THE FOLLOWING DAY ((B)(6)). PT CALLED THIS MORNING ((B)(6)) AND SAID ALTHOUGH SHE FELT BETTER, SHE WAS STILL LIGHT SENSITIVE AND WOULD COME IN TOMORROW ((B)(6)). PT RETURNED TO CLINIC (B)(6) 2018 AND CONDITION HAD RESOLVED. THERAPY DATE: (B)(6) 2018. OTC PRODUCT. FREQUENCY: ONCE; ROUTE: OPHTHALMIC. REASON FOR USE: CONTACT LENS STORAGE. GENERIC CONTACT LENS SOLUTION (WITHOUT BAK).