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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/22/2020

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.The manufacturer internal reference number is: (b)(4).

Event Description

A facility representative reported two "defective shunts" during surgery.The procedure was completed with an alternate device without patient harm.Additional information has been requested however, further information is not available for this report.

Manufacturer Narrative

Additional information was requested however, further information was not received.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.All products pass 100% final inspection prior to approval.The root cause could not be determined.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: 10485851
• MDR Text Key: 215573806
• Report Number: 3003701944-2020-00032
• 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: other
• Type of Report: Initial,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P-50 PL
• Device Catalogue Number: 47053
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1