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

Model Number	BG103-250
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Eye Injury (1845); Inflammation (1932); Red Eye(s) (2038); Excessive Tear Production (2235)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown; requested but not provided.Date of event: unknown; requested but not provided.The best estimate date is between (b)(6) 2021 and (b)(6) 2023.Section d6b: if explanted, give date: unknown, information was requested but not provided.The best estimate date is may 2022.The device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Multiple attempts have been made to obtain additional information regarding the event; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that after the glaucoma implant was implanted on (b)(6) 2021, it was then removed in may 2022.The patient is experiencing inflammation, irritation, and constant watering of the eye.The patient believes the body has rejected the implant.The patient is currently under treatment with the same implanting physician and on the following medications: prednisone for 3 days; eorzolamieehci ,timololmaleate; bromfenac solution.The patient reported having permanent eye and optic damage and is suggesting that it might be the implant.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: 16401660
• Report Number: 3012236936-2023-00386
• Device Sequence Number: 5705746
• Product Code: KYF
• UDI-Device Identifier: 05050474513013
• UDI-Public: (01)05050474513013(17)220423
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K905129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/23/2022
• Device Model Number: BG103-250
• Device Catalogue Number: 23030819
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 02/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male