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

Model Number P-50 PL

Device Problem Defective Device (2588)

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

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was returned for analysis.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.Results from the product history record review indicated the product met release criteria.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that during a glaucoma filtration device (gfd) implant procedure, the device was unable to be released.The procedure was completed with a different device.

Manufacturer Narrative

The sample was received for investigation: the sample was returned in an open secondary package.The sample included labels, instructions for use (ifu, delivery system (eds) placed in cradle sealed in pouch and the device.The product was packed in a non-original pouch which is very different from the original one.The eds wire was slightly pressed.The device was placed on the tip of eds cannula.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 the manufacturer's release criteria.No other complaints for the lot.As part of investigation, push force test was performed.The device was released from eds wire after applying the required force.All products pass 100% final inspection at the manufacturer prior to approval.If a defect would be noticed, the product would have been rejected.The root cause cannot be determined since the eds wire was slightly pressed and the push force test was successfully passed.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: 10018332
• MDR Text Key: 194109229
• Report Number: 3003701944-2020-00020
• 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: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: P-50 PL
• Device Catalogue Number: 60053
• Device Lot Number: 073405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2020
• Date Manufacturer Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1