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

Catalog Number	8065752212
Medical Device Problem Codes	Fluid/Blood Leak (1250); Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that cassette leaked water caused no aspiration during the cataract with intraocular lens implant surgery.The surgery was completed after replacing the product with another one.There was no impact to the patient.
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Additional Manufacturer Narrative
Correction information was provided in b.5 and h.11.Upon further assessment it was confirmed that the issue was related to the cassette leakage.Hence this is not considered to be a reportable malfunction, and it is not likely that a recurrence would result in serious injury.No further reports will be submitted under mfg report num.9681121-2026-00069.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: 24684820
• Report Number: 9681121-2026-00069
• Device Sequence Number: 18636009
• Product Code: LRO
• UDI-Device Identifier: 00380657522125
• UDI-Public: (01)00380657522125(17)270901(11)250919(10)31607104
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 8065752212
• Device Lot Number: 31607104
• 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: 03/01/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 04/29/2026
• Date Device Manufactured: 09/19/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CENTURION SURGICAL PROCEDURE PAK.
• Patient Sex: Unknown