MAUDE MDR 1940516

MDR report key
1940516
Report number
9614392-2010-00018
Event key
0
Event type
3
Date received
2010-12-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
ANNETTE NELSON
Address
6150 STONERIDGE MALL ROAD STE. 370 PLEASANTON CA 94588 US
Phone
925-925-9259
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BIOFINITY TORIC (COMFILCON A)LPM, SOFT CONTACT LENS, EXTENDED WEARCOOPERVISION MANUFACTURING, LTD.LPMUNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-12-2101. O

Event Narratives#

D

Patient 1

PATIENT WAS EXPERIENCING PAIN WITH HER LEFT EYE AFTER FALLING ASLEEP WITH HER BIOFINITY TORIC CONTACT LENSES. ON EXAMINATION, THE PATIENT HAD A VISUAL ACUITY OF 20/20 OD AND 20/30 OS. HER RIGHT CORNEA WAS CLEAR, BUT SHE HAD TWO CORNEAL ULCERS ON HER LEFT CORNEA. THE LEFT CONJUNCTIVA WAS 'MARKEDLY INJECTED." ANTERIOR CHAMBERS WERE DEEP AND QUIET. IOPS WERE NORMAL AT 16MMHG OU. FUNDOSCOPY REVEALED HEALTHY OPTIC DISCS AND MACULAE. THE PATIENT IS BEING TREATED WITH AN INTENSIVE TOPICAL ANTIBIOTIC REGIMENT, AND IS RESPONDING WELL TO TREATMENT.

N

Patient 1

EVAL METHOD: NO LOT INFO, NO LENSES, NO DEVICE INFO, NO EXAMINATION OF DEVICE WERE PROVIDED WHICH COULD INDICATE IF THE DEVICE CAUSED OR CONTRIBUTED TO THE INCIDENT. RESULTS: WE ARE REPORTING THIS BECAUSE WE CANNOT CONFIRM THAT THERE WAS NO PERMANENT IMPAIRMENT OR PERMANENT DAMAGE. THERE IS NO CLEAR INDICATION THAT THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN. SHOULD FURTHER INFO BE PROVIDED THAT WOULD CHANGE THIS CONCLUSION, AN UPDATE TO THIS REPORT WILL BE PROVIDED WITHIN ONE MONTH OF RECEIPT OF THE ADD'L INFO.