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

Model Number	BG103-250
Medical Device Problem Codes	Complete Blockage (1094); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5, a6, patient information: unknown/not provided.Section d6a, if implanted, give date: not applicable as the product was not implanted.Section d6b, if explanted, give date: not applicable as the product was not implanted.Therefore, 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.
Event or Problem Description
The following was reported regarding the johnson (jnj) glaucoma shunt.The surgeon said that the product feels different and asked if the material had changed.The surgeon recently severed a shunt while tying with a suture and has never had this happen before.What the surgeon found most concerning is that after she tied off the tube, when she then injected balance salt solution (bss) into the tube, it swelled up, expanded like an inner tube."that never happened before".No further information was provided.

• 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: 25194668
• Report Number: 3012236936-2026-000137
• Device Sequence Number: 10388500
• Product Code: KYF
• UDI-Device Identifier: 05050474513013
• UDI-Public: (01)05050474513013(17)270924
• Combination Product (Y/N): N
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2026

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: BG103-250
• Device Catalogue Number: 23030819
• 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: 04/29/2026
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 05/15/2026
• Supplement Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2025
• 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