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	Endophthalmitis (1835); Loss of Vision (2139)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per regulation eu (b)(4) (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Date of event: unknown/not provided.Best estimate year is in 2022.If implanted, give date: unknown / not provided.If explanted, give date: unknown / not provided.Telephone number: unknown / not provided.Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the intraocular lens were reviewed.The product was manufactured according to specifications.The search revealed that no similar complaint for this production order number has been received.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.Attempts have been made to obtain missing information; however, the consumer did not have the information.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported by the patient's parent that their daughter had two baerveldt glaucoma shunts implanted tin both eyes in 2019.In 2020, the patient had orbital panophthalmitis in the right eye with no complications; however, sometime in 2022, the patient had panophthalmitis in the left eye.The baerveldt glaucoma shunt was extracted from the left eye and that left eye lost vision.Through follow-up, it was learned that the glaucoma implant was extracted from the left eye due to a streptococcus aureus infection which started with an orbital cellulitis that developed into endophthalmitis.Baerveldt glaucoma shunt served as an entry mode for the infection.The final diagnosis was endophthalmitis septal cellulitis with panophthalmitis.The vision was completely lost and there is no subsequent perception of light.Patient is under constant observation, because she also has an implant in the right eye.The patient's parent was not provided any other information, therefore, had limited information to provide johnson & johnson surgical vision.Patient had bilateral glaucoma implants.This report captures the glaucoma implant in patients left eye.Only the left eye had the reportable issue.

• 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: 14190901
• Report Number: 3012236936-2022-01068
• Device Sequence Number: 4474348
• Product Code: KYF
• UDI-Device Identifier: 05050474512993
• UDI-Public: (01)05050474512993(17)200709
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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: Other,Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2022

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: 07/09/2020
• 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: 03/27/2022
• Initial Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2018
• 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: Female