MAUDE MDR 4473184

MDR report key
4473184
Report number
3005087645-2015-00001
Event key
0
Event type
3
Date of event
2014-11-06
Date received
2015-01-30
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
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 LENSCONTACT LESNSYNERGEYES, INC.HQDAS7686+0325059228Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-01-3001. R

Event Narratives#

D

Patient 1

ON JANUARY 14, 2015, SYNERGEYES RECEIVED A COMPLAINT WHEREIN THE REASON FOR RETURN WAS ULCER. THE REPORT STATE: "PATIENT NOTICED DISCOMFORT" ON THE DATE (B)(6) 2014. IT WAS INDICATED THAT THE PT HAD NO PRE-EXISTING OR RECURRING CONDITIONS THAT MAY HAVE PRECEDED THE ULCER. TREATMENT WAS ADMINISTERED BY A DIFFERENT PRACTICE WHILE THE PT WAS AWAY FOR COLLEGE. BETWEEN (B)(6) 2015, FOUR CALLS WERE MADE TO (B)(6) FROM THE (B)(6). ON (B)(6) 2015, SYNERGEYES CONTACTED (B)(6) AND THE FOLLOWING INFORMATION WAS OBTAINED: CONDITIONS HAS RESOLVED WITH NO SECONDARY COMPLICATIONS. PT IS DOING WELL WITH REPLACEMENT LENSES DISPENSED ON (B)(6) 2014. THERE WAS A FOLLOW-UP APPOINTMENT WITH THE PT ON (B)(6) 2014 WITH NO INDICATION OF CONDITION RECURRENCE. ZYMAXID AB TOPICAL DROPS WERE PRESCRIBED BY ANOTHER ECP, PT MENTIONED AN ORAL PILL HAD BEEN TAKEN, BUT (B)(6) DID NOT AT THE TIME KNOW WHICH PILL. (B)(6) WOULD TRY TO CONTACT PT TO SEE IF PT WAS WILLING TO SIGN A RELEASE OF INFORMATION FORM. ON (B)(6), (B)(6) WAS CONTACTED AGAIN AND SHE STATED THAT THE PT HAD BEEN WILLING TO SIGN THE RELEASE AND WAS WAITING FOR THE RECORDS TO BE SENT. ON (B)(6), (B)(6) WAS CONTACTED A FINAL TIME AND HAD THE RECORDS. THE FOLLOWING INFORMATION WAS OBTAINED: (B)(6) IS THE CLINIC THE PT VISITED NEAR THE COLLEGE. THE ORAL PILL PRESCRIBED WAS BENADRYL. THE CONDITION WAS NOT PRE-EXISTING, NO INFORMATION ON FILE REGARDING WHETHER ECP THROUGH ULCER WAS DUE TO THE LENS.

N

Patient 1

DURING THE INVESTIGATION THE FOLLOWING INFORMATION WAS OBTAINED: BASE CURVE WAS MEASURED BY RADIUS SCOPE AND POWER WAS MEASURED BY RADIUS SCOPE AND POWER WAS MEASURED BY LENSOMETER. BOTH BC AND POWER WERE FOUND TO BE WITHIN SPECIFICATIONS. DURING SURFACE INSPECTION, THE LENS WAS ABLE TO WET PROPERLY AFTER CLEANING AND ALTHOUGH A KNOWN STIPPLING EFFECT WAS FOUND ON THE SOFT SKIRT FO THE LENS, IT PASSED THE MANUFACTURING SPECIFICATIONS AND IS UNLIKELY TO HAVE CONTRIBUTED TO THE ALLEGED INJURY. NO CORRELATION WAS FOUND BETWEEN THE ALLEGED INJURY AND THE DEVICE HISTORY REPORT.