MAUDE Adverse Event Report: OPTONOL LTD. EX-PRESS GLAUCOMA FILTRATION DEVICE; IMPLANT, EYE VALVE

Model Number P-50 PL

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/20/2018

Event Type  malfunction  

Manufacturer Narrative

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.Additional information was requested.(b)(4).

Event Description

A physician reported that during a glaucoma filtering shunt procedure, the shunt would not release from the delivery system when inserted into a patient's eye.Another shunt was implanted instead.There was no reported harm to the patient.

Manufacturer Narrative

The sample was received and its investigation may be summarized as follows: the delivery system (ds) wire was pressed down.The ds wire partially protruded from the cannula opening.The shunt was sent in a separate plastic bag.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 one similar complaint for the reported lot.All products pass 100% final inspection prior to approval.If a defect would be noticed, the product would have been rejected.The root cause cannot be identified 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).

• Brand Name: EX-PRESS GLAUCOMA FILTRATION DEVICE
• Type of Device: IMPLANT, EYE VALVE
• Manufacturer (Section D): OPTONOL LTD.; kiryat hatikshoret; communication center; neve-ilan 90850 ; IS 90850
• MDR Report Key: 8257819
• MDR Text Key: 133828787
• Report Number: 3003701944-2019-00004
• Device Sequence Number: 1
• Product Code: KYF
• Combination Product (y/n): N
• PMA/PMN Number: K012852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: P-50 PL
• Device Catalogue Number: 60053
• Device Lot Number: 073119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Date Manufacturer Received: 03/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1