FDA.reportPublic FDA data

MAUDE MDR 3883639

MDR report key
3883639
Report number
3005087645-2014-00014
Event key
0
Event type
3
Date of event
2014-03-20
Date received
2014-06-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
KAREN KINCADE, DIRECTOR
Address
2232 RUTHERFORD ROAD CARLSBAD CA 92008 US
Phone
760-760-7604
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SYNERGEYES HYBRID CONTACT LENS - KSCONTACT LENSSYNERGEYESHQDKS6785-1450056131Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-06-0901. R

Event Narratives#

D

Patient 1

ON (B)(4) 2014, SYNERGEYES RECEIVED A COMPLAINT WHEREIN PT SUSTAINED A CORNEAL ULCER IN THE RIGHT EYE (OD). PT ALSO EXPERIENCED "SLIGHT IRRITATION." ATTENDING EYE-CARE PROFESSIONAL (ECP) PRESCRIBED TOBRADEX FOR SYMPTOMS IN THE LEFT EYE (OS). COMPLAINT STATES THAT SYMPTOMS SURFACED (B)(6) 2014, HOWEVER "ALL SYMPTOMS HAVE BEEN RESOLVED AS OF NOW." WHEREIN, "NOW" REFERS TO (B)(6) 2014. FROM (B)(6) 2014, SEVERAL ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL EVENT INFORMATION FROM ECP. ON (B)(6) 2014, SYNERGEYES SPOKE WITH DR (B)(6) REGARDING THE EVENT AND PT. THE FOLLOWING WAS DISCLOSED: PT HAS A HISTORY OF OVER WEARING LENSES. FOR EXAMPLE: PT WORE LAST SET OF SYNERGEYES LENS FOR LONGER THAN ONE YEAR, WHEN THE RECOMMENDED LENGTH IS 6 MONTHS, THE LENSES MENTIONED WERE ORDERED (B)(6) 2009. NEW LENSES ORDERED IN THE SAME PARAMETERS ON (B)(6) 2014 WERE UNCOMFORTABLE FOR PT AND PT DEVELOPED REDNESS AND IRRITATION WITH PAIN GREATER IN OD THAN IN OS. AT A FOLLOW UP VISIT, PT EXHIBITED A "MECHANICAL" STERILE ULCER IN THE RIGHT EYE JUST OUTSIDE THE JUNCTION. THIS CLEARED COMPLETELY WITH TREATMENT. A TECHNICIAN FROM THE ECP PRACTICE CALLED SYNERGEYES CONSULTATION ON (B)(6) 2014 AND INQUIRED ABOUT OS LENS TURNING EYE "RED." SYNERGEYES CONSULTANT INSTRUCTED LAB TECH TO SWITCH LENSES TO SEE IF PROBLEM FOLLOWED LENS TO OD OR REMAINED ONLY IN OS. AS INSTRUCTED BY DR (B)(6) THIS WAS NEVER DONE. INSTEAD, DR (B)(6) RETURNED LENSES AND REORDERED THE SAME PRESCRIPTION (RX) FOR BOTH EYES, TO VERIFY IF ORIGINAL LENSES WERE "BAD". OS RX WAS ORDERED ON (B)(6) 2014 AND OD RX ON (B)(6) 2014. PT IS DOING WELL WITH NEW LENSES FOR BOTH EYES.

N

Patient 1

SECOND DEVICE RETURNED: MODEL # KS6785-1550, LOT #: 052049, EXPIRATION DATE: 06/01/2018, MANUFACTURE DATE: 07/01/2013. DURING THE INVESTIGATION, THE FOLLOWING INFORMATION WAS OBTAINED. DEVICE 1: BASE CURVE MEASURED BY RADIUS SCOPE AND POWER MEASURED BY LENSOMETER, BOTH BC AND POWER WERE FOUND TO BE WITHIN SPECIFICATIONS. NO DEFECTS WERE NOTED ON SURFACE AND NO CORRELATION WAS FOUND BETWEEN THE ALLEGED INJURY AND THE LENS PROCESSING HISTORY. DEVICE 2: BASE CURVE MEASURED BY RADIUS SCOPE AND POWER MEASURED BY LENSOMETER. BOTH BC AND POWER WERE FOUND TO BE WITHIN SPECIFICATIONS. NO DEFECTS WERE NOTED ON SURFACE AND NO CORRELATION WAS FOUND BETWEEN THE ALLEGED INJURY AND THE LENS PROCESSING HISTORY.