FDA.reportPublic FDA data

MAUDE MDR 8137542

MDR report key
8137542
Report number
0001313525-2018-00226
Event key
0
Event type
3
Date of event
2018-06-11
Date received
2018-12-06
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#

Contact
MS. JENNIFER GAMET
Address
1400 NORTH GOODMAN STREET ROCHESTER NY 14609 US
Phone
585-585-5853
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BIOTRUE ONEDAY(NESOFILCON A)CONTACT LENSLENS, CONTACT, DISPOSABLEBAUSCH & LOMB INCORPORATEDMVNW77249902R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-12-0601. O

Event Narratives#

N

Patient 1

IT WAS CONFIRMED WITH THE SPECIALIST OFFICE THAT IT IS UNCLEAR IF THE CONSUMER WILL HAVE PERMANENT LOSS OF VISION. THEY ATTRIBUTE THE CAUSE OF THE ULCER TO BE CONTACT LENS WEAR. THE CONSUMER DISCARDED THE COMPLAINT LENS, THEREFORE IT IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS CONCLUDES THAT THE PRODUCT WAS MANUFACTURED, PACKAGED AND RELEASED ACCORDING TO GLOBAL AND PLANT PRODUCT SPECIFICATIONS. BASED ON ALL AVAILABLE INFORMATION, NO CAUSAL FACTORS CAN BE DETERMINED AND NO CONCLUSION CAN BE DRAWN.

D

Patient 1

MEDWATCH REPORT RECEIVED FROM FDA, MW5080879. THROUGH THE MEDWATCH PROGRAM IT WAS REPORTED THAT THE CONSUMER HAD A RAPID ONSET OF A SEVERE INFECTION IN THE RIGHT EYE WHICH LED TO PERMANENT VISION IMPAIRMENT. FOLLOW UP WITH THE CONSUMER REVEALED THAT AFTER WEARING THE LENSES FOR 12 HOURS, THEY HAD A VERY RAPID ONSET OF RED EYE, PAIN, TEARING, DISCOMFORT AND BLURRY VISION IN THE RIGHT EYE. THE NEXT DAY, (B)(6) 2018, THE CONSUMER VISITED THE CORNEAL SPECIALIST DOCTOR WHERE THEY WERE DIAGNOSED WITH A CENTRAL CORNEAL ULCER. THE EXACT DIMENSIONS ARE NOT AVAILABLE. CONFIRMED WITH THE SPECIALIST THAT A CORNEAL SCRAPING WAS TAKEN, HOWEVER IT WAS NEGATIVE FOR BACTERIAL GROWTH. THE PATIENT WAS PRESCRIBED FORTIFIED VANCOMYCIN, FORTIFIED TOBRAMYCIN AND PREDNISOLONE ONCE A DAY. THE ANTIBIOTICS WERE DISCONTINUED IN (B)(6); THEY ARE STILL CURRENTLY USING PREDNISOLONE FOR INFLAMMATION. THE PATIENT FOLLOWED UP WITH THE DOCTOR EVERY 4 DAYS UNTIL (B)(6). IN (B)(6) THEY FOLLOWED UP WEEKLY UNTIL (B)(6), WHERE THEY ARE NOW FOLLOWING UP MONTHLY. IT WAS CONFIRMED WITH THE SPECIALIST OFFICE THAT AT NO TIME WAS THE ULCER INFECTIOUS. THE PATIENT HAS MOSTLY RECOVERED EXCEPT THEY HAVE A CORNEAL SCAR WHICH POTENTIALLY CAN CAUSE PERMANENT LOSS OF VISION. THEY ARE CURRENTLY BEING SEEN BY AN OPTOMETRIST TO BE REFIT INTO CONTACT LENSES TO ACCOMMODATE THE CHANGE IN VISION. THE SPECIALIST ATTRIBUTES THE EVENT TO CONTACT LENS WEAR. EVERY TIME THE PATIENT VISITS THE SPECIALIST?S OFFICE THEIR VISION READS DIFFERENTLY, IT IS DIFFICULT TO TELL IF IT WILL CAUSE PERMANENT VISION LOSS.