FDA Adverse Event Malfunction Summary report: N

EX-PRESS GLAUCOMA FILTRATION DEVICE

MDR report key: 8771852 · Received July 9, 2019

Report

Report Number: 3003701944-2019-00020
Event Type: Malfunction
Date Received: July 9, 2019
Report Date: September 19, 2019
Manufacturer: OPTONOL LTD.
Product Code: KYF
PMA / PMN Number: K012852
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 0

THE SAMPLE HAS BEEN RECEIVED AND INVESTIGATED: THE SAMPLE WAS RETURNED IN AN OPEN SECONDARY PACKAGE. THE SAMPLE INCLUDED A DELIVERY SYSTEM (DS), A SHUNT ON A GAUZE PIECE INSIDE THE SEPARATE PLASTIC BAG, IFU AND LABELS. THE DS WIRE WAS PRESSED DOWN. THE DS WIRE DIDN¿T PROTRUDE FROM THE CANNULA OPENING. THE ROOT CAUSE IS INCONCLUSIVE - UNABLE TO VERIFY AS THE DS TRIGGER WAS OPERATED AND PERFORMED ITS FUNCTIONALITY RELEASING THE SHUNT (SHUNT WAS RECEIVED SEPARATELY FROM THE DS). THE COMPLAINT CANNOT BE CONFIRMED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

Additional Manufacturer Narrative · 1

INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE DEVICE HISTORY RECORD (DHR) FOR THE BATCH WAS REVIEWED. NO ABNORMALITIES WERE FOUND DURING THE DHR REVIEW AND THE PRODUCT WAS RELEASED ACCORDING TO RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS FOR THE LOT. (B)(4).

Description of Event or Problem · 1

A SURGEON REPORTED THAT DURING A GLAUCOMA FILTERING DEVICE (GFD) IMPLANTATION SURGERY, THE DEVICE WOULD NOT RELEASE FROM THE DELIVERY SYSTEM. ANOTHER SHUNT WAS IMPLANTED INSTEAD. ADDITIONAL INFORMATION WAS NOT AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
564040	EX-PRESS GLAUCOMA FILTRATION DEVICE	IMPLANT, EYE VALVE	KYF	OPTONOL LTD.	P-50 PL	073190

Patients

Seq	Age	Sex	Outcome	Treatment
1