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

Model Number P-50 PL

Device Problem No Flow (2991)

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

Event Date 07/19/2018

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.(b)(4).

Event Description

A customer reported during a glaucoma filtration device implant procedure, no flow was confirmed.The device was removed and replaced with a backup during the initial procedure.

Manufacturer Narrative

Additional information provided.A customer reported that ¿no flow of aqueous humor was confirmed while inserting ¿ and the shunt was explanted.The product was returned for investigation and received in the following manner: the sample was return in an original, outer open box.The eds returned for investigation placed in open pouch.The shunt returned in a plastic bag, separated from the eds.Eds wire is press down and a bit protruded from the cannula opening.The shunt was clean and undamaged.Inner illumination insp.: the shunt found to be open.There was no indication of manufacturing related factors that could cause the reported event.There are no additional complaints for this lot.All products pass 100% final inspection prior to approval.If a defect would be noticed, the product would have been rejected.Having said that, one may conclude that the blockage was formed after the product left the manufacturing plant.The root cause is inconclusive - unable to verify, since the blockage could have been caused by many different reasons during the clinical procedure.The blockage does not seem to be product related since, found to be open.Therefore, there is no evidence for an inherent defect that might have caused the event.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: 7797352
• MDR Text Key: 117847376
• Report Number: 3003701944-2018-00046
• 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: 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: P-50 PL
• Device Catalogue Number: 60053
• Device Lot Number: 073089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Date Manufacturer Received: 10/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other