MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS BAERVELDT SHUNT; IMPLANT, EYE VALVE

Model Number	BG102-350
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the water flow in a glaucoma implant shunt was checked during the pre-operative preparation stage and the water did not flow or it was difficult to get through.The customer then replaced it with a new product.The patient is ok.No other information was provided.
Additional Manufacturer Narrative
Implant date: if implanted, give date: not applicable, as there was no patient contact with the device.Explant date: if explanted, give date: not applicable, as there was no patient contact with the device.Initial reporter name and address:: telephone number: (b)(6).The device is not returned; therefore, a failure analysis of the complaint device cannot be completed.A review of the device record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Section d9.Device available for evaluation? yes returned to manufacturer on: jul.12, 2022 section h3.Device evaluated manufacturer? yes device evaluation: the product was received in the original packaging.The product was disinfected according to procedure.Product evaluation was performed under magnification.Additional testing was not performed.The results of the inspection shows that there is no problem with the tubing.Based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Therefore, there is no indication of a product deficiency or product malfunction.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: BAERVELDT SHUNT
• Common Device Name: IMPLANT, EYE VALVE
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 15021906
• Report Number: 3012236936-2022-01772
• Device Sequence Number: 20547217
• Product Code: KYF
• UDI-Device Identifier: 05050474513006
• UDI-Public: (01)05050474513006(17)220904
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955455
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/04/2022
• Device Model Number: BG102-350
• Device Catalogue Number: 23030818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 01/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown