MAUDE Adverse Event Report: PT. CIBA VISION Batam CENTURION Surgical Procedure Pak; General surgery tray (kit)

Catalog Number	8065752201
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported that the balance tip was bent before cataract (without intraocular lens implant) surgery.The surgery was completed on the same day after replacing the pack with another one.There was no information about patient impact.
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).

• 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 ; +1(800)757-9780
• MDR Report Key: 50888687
• Report Number: 9681121-2026-00297
• Device Sequence Number: 16141016
• Product Code: LRO
• UDI-Device Identifier: 00380657522019
• UDI-Public: (01)00380657522019(17)280301(11)260304(10)31621231
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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
• Report Date (Section B): 09/24/2026

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: 8065752201
• Device Lot Number: 31621231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 03/04/2026
• 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