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

Catalog Number ALCUNK00059

Device Problem Malposition of Device (2616)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2022

Event Type  Injury  

Event Description

A physician reported following an glaucoma shunt implant procedure, the glaucoma filtration device has shifted outward in the eye.The patient has now been admitted to hospital as an inpatient.Additional information has been requested and received which states that the patient was already operated on earlier that day, so information is not needed urgently anymore.Patient is doing fine so far.

Manufacturer Narrative

A sample device was not returned for analysis.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.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information provided in h.3., h.6.And h.10.A sample was not received at the manufacturing site for evaluation; therefore, the condition of the product could not be evaluated.Due to insufficient data and no sample received, the customer reported event could not be confirmed.Based on the complaint reported event, the complaint review activities and sample evaluation that could not be conducted, - no evidence has been presented, obtained or identified concluding the device failed to meet specification, - the device was used for treatment according to the reported event.- relationship of the device to the reported incident: according to the event description hcp reported the device is related to the incident however this could not be determined at this time by the manufacturing site.Since the root cause cannot be determined, no additional action can be taken at this stage.Per most recent trending, no associated trend alert was observed.All complaints are reviewed on a monthly basis, and corrective actions will be defined if required.The company has reviewed this complaint and will continue to monitor data for evidence of adverse trends and take further action, as appropriate.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: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 13735222
• MDR Text Key: 287022157
• Report Number: 3003701944-2022-00003
• Device Sequence Number: 1
• Product Code: KYF
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K012852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ALCUNK00059
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female