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

Model Number	BG101-350
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Excessive Tear Production (2235); Unspecified Eye / Vision Problem (4471)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d-6b date explanted: not applicable as the glaucoma implant remains implanted in the patient¿s ocular sinister (left eye), therefore not explanted.Section h3: the device was not returned for evaluation as it remains implanted.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 report will be filed.Section h-6 health effect - clinical code: 4471 - is to capture pupil dilated and patient feeling unwell/sick.Attempts were made to obtain the missing information; however, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the bg101-350 model glaucoma implant was implanted into the patient¿s ocular sinister (left eye) to address high eye pressure.The patient reported fluctuations in eye pressure and experienced excessive watery eyes.The patient reported the following events with the eyes.Glaucoma surgery resulting in two intraocular lens (iol) implants and had laser surgery.The patient reported no issues with the product.The patient is disabled from an unrelated health issue (poor back and rotator cuff).The shunts were put in due to very low pressure; 1% in left eye and 5% in the right.The patient was prescribed four antibiotics.The patient stated that the eyes were watering so much that the patient stopped taking the medication and ended up with eye pressure of 40.The doctor removed "rip cords" from the shunts and mentioned that the patient may need additional sutures.On monday (unspecified date), the patient went to see the doctor because the eyes stayed dilated and made the patient feel sick.The doctor removed the rip cords and discovered ulcers in the right eye.In addition, there was an issue that required three tries to remove the rip cords.The patient reported that if the eye "perforates" the doctor will need to do an additional surgery.No further information is available.This report is to capture the left eye event.A separate report will be submitted to capture the right eye event.

• 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: 19217956
• Report Number: 3012236936-2024-000126
• Device Sequence Number: 20568438
• Product Code: KYF
• UDI-Device Identifier: 05050474512993
• UDI-Public: (01)05050474512993(17)220127
• 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): 04/30/2024

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: 01/27/2022
• Device Model Number: BG101-350
• Device Catalogue Number: 23030817
• 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: 04/03/2024
• Initial Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2020
• 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 Age: 62 YR
• Patient Sex: Male