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

Model Number P-200 PL

Device Problem No Flow (2991)

Patient Problem Intraocular Pressure Increased (1937)

Event Date 05/08/2021

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: 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 manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that during a glaucoma filtration device (gfd) implant procedure, no fluid came through the device causing high intraocular pressure (iop).A new device was used and the surgery was completed.

Manufacturer Narrative

There have been no other complaints for this lot.The sample has not been received; therefore, the condition of the product could not be verified and visual inspection could not be performed.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.All products pass 100% final inspection at the manufacturer prior to approval.If a defect would be noticed, the product would have been rejected.Since the sample has not been received, the root cause can not be determined and 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: 11878031
• MDR Text Key: 281149517
• Report Number: 3003701944-2021-00015
• 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: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: P-200 PL
• Device Catalogue Number: 24203
• Device Lot Number: 073457
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1