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

Model Number	BG101-350
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the johnson and johnson (jnj) glaucoma implant was not flushing properly.The doctor systematically checks each baerveldt implant to ensure they flush properly before implantation, but this particular implant failed the test.It seems the shunt was occluded.The doctor flushes or attempts to flush the baerveldt shunt on the sterile field.If it does not flush it does not touch the eye.No further information was provided.
Additional Manufacturer Narrative
Section d6a, if implanted, give date: not applicable.There is no indication the device was implanted.Section d6b, if explanted, give date: not applicable.There is no indication the device was implanted.Therefore, it was not explanted.Section h3, device evaluated by manufacturer: the device has not been returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record and complaint trending will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain the missing information.However, to date, it has not been received.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: 21859515
• Report Number: 3012236936-2025-000108
• Device Sequence Number: 7898475
• Product Code: KYF
• UDI-Device Identifier: 05050474512993
• UDI-Public: (01)05050474512993(17)270114
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K905129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/10/2025

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 Model Number: BG101-350
• Device Catalogue Number: 23030817
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Initial Report FDA Received Date: 04/17/2025
• Date Device Manufactured: 01/14/2025
• 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