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 10/31/2016

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, it was confirmed there was no flow of aqueous humor.The device was removed and a backup device was implanted during the initial procedure.Additional information was requested.

Manufacturer Narrative

Customer reported that there was no flow of aqueous humor, suspected clogged shunt; the shunt explanted and another one implanted.There is no similar complaint from this lot.The product was returned for investigation and was found in the following manner: the explanted shout was not receive.Only eds and cradle were receive for investigation.Therefore, the condition of the shunt couldn¿t be checked, and the complaint could not be confirmed.The device history record (dhr) for the batch was reviewed.The product was released according to approved release criteria.All products pass 100% final inspection prior to approval, several times.If such a defect would be noticed, the product would have been rejected and segregated immediately.Root cause cannot be identified as the primary package was opened; therefore, there is no way to determined how and when the shunt fell off the eds.Because the root cause cannot be determined, no additional action can be taken at this stage.Quality assurance performs periodic monitoring of similar incidents and will take action if an unfavorable trend occurs.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
• Manufacturer (Section G): OPTONOL LTD.; kiryat hatikshoret; communication center; neve-ilan 90850 ; IS 90850
• Manufacturer Contact: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6135588
• MDR Text Key: 61469245
• Report Number: 3003701944-2016-00223
• Device Sequence Number: 1
• Product Code: KYF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K012852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: P-50 PL
• Device Catalogue Number: 60053
• Device Lot Number: 072646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2016
• Initial Date FDA Received: 11/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/31/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other