MAUDE Adverse Event Report: PT. CIBA VISION BATAM CENTURION SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)

Catalog Number	8065752212
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Intraocular Pressure Decreased (4468)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that there was poor fluid flow when using the fluidic management system (fms), resulting in unstable anterior chamber during the cataract [without intraocular lens (iol) implant] surgery.The surgery was completed after replacing the product with new product.There was no patient impact.
Additional Manufacturer Narrative
Additional information provided in h.6.And h.11.No photo and/or video was provided by the reporter, and a sample was not received at the investigation site for evaluation; therefore, the condition of the complaint product could not be evaluated.The investigation conducted a non-conformance review of the reported 31600972 number.No deviations were identified and all corresponding production release specifications defined in the device master record were met.No similar complaint under this lot.Manufacturing device history record (dhr) review was performed to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.The root cause of the reported event has been determined to be inconclusive since no returned sample received to confirm this event.This lot had passed all the required inspections and specification during manufacturing process prior to release.No potential contributory factors and abnormalities found in process and inspection during manufacturing process that related to the reported complaint event.The root cause of the reported event has been determined to be inconclusive.Based on review of the manufacturing device history record (dhr) and information available in the complaint record, there is no impact to the other product and no serious impact to the patient.No escalation/faa/market action is required.No corrective and preventive action (capa) will be initiated for this complaint.Quality assurance has reviewed, evaluated, and investigated this complaint.No adverse trends have been observed associated with the reported product and event based on the latest monitoring review.No further action has been identified for this reported event.Monitoring data will continue for evidence of adverse trending and take further action, if appropriate.Receipt of complaint sample or additional information pertinent to this complaint will result in re-evaluation of the complaint investigation.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION SURGICAL PROCEDURE PAK
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): PT. CIBA VISION BATAM; beringin kav. #204 batamindo; industrial park muka kuning; pulau batam 29433 ; ID 29433
• Manufacturer (Section G): PT. CIBA VISION BATAM; beringin kav. #204 batamindo; industrial park muka kuning; pulau batam 29433 ; ID 29433
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 23739700
• Report Number: 9681121-2025-00182
• Device Sequence Number: 21370012
• Product Code: LRO
• UDI-Device Identifier: 00380657522125
• UDI-Public: (01)00380657522125(17)270701(11)250707(10)31600972
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

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 Catalogue Number: 8065752212
• Device Lot Number: 31600972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 03/03/2026
• Date Device Manufactured: 07/07/2025
• 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