MAUDE Adverse Event Report: OPTONOL, LTD EX-PRESS MINI GLAUCOMA SHUNT; AQUEOUS SHUNT

Model Number P-50 PL

Device Problems Defective Component (2292); No Flow (2991)

Patient Problem No Information (3190)

Event Date 09/25/2014

Event Type  malfunction  

Event Description

A customer called to report that a glaucoma filtration device was defective.Pt harm is unk.The device would not allow fluid flow.A trabeculectomy was required.Additional info was requested.

Manufacturer Narrative

Evaluation summary: no sample was returned, therefore, the condition of the product could not be verified and visual inspection cannot 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 release criteria.Because a sample was not returned, the root cause cannot be determined.There have been no other complaints reported in the lot number.Attempts have been made to obtain additional info by phone, fax, and e-mail.A completed questionnaire was not received.(b)(4).

• Brand Name: EX-PRESS MINI GLAUCOMA SHUNT
• Type of Device: AQUEOUS SHUNT
• Manufacturer (Section D): OPTONOL, LTD; communication center; neve ilan 90850 ; IS 90850
• Manufacturer (Section G): OPTONOL, LTD; communication center; neve ilan 9085 0; IS 90850
• Manufacturer Contact: janet moran ; 6201 south freeway, r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 4187987
• MDR Text Key: 5160622
• Report Number: 3003701944-2014-00194
• Device Sequence Number: 1
• Product Code: KYF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030350
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 09/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2017
• Device Model Number: P-50 PL
• Device Catalogue Number: 40753
• Device Lot Number: 134903
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• 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