MAUDE Adverse Event Report: PT. CIBA VISION BATAM ACRYSOF MULTIPIECE IOL; INTRAOCULAR LENS

Model Number	MA60AC
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A pharmacist reported with a description of intraocular lens (iol) damaged, making it impossible to place in the patient's eye.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was provided in d.3., g.1., g.8.And h.11.D.3.Product manufacturing site updated due to receipt of serial number.G.8.Manufacturer report number corrected and reported under 9681121-2025-00168.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF MULTIPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): PT. CIBA VISION BATAM; beringin kav. #204 batamindo; industrial park muka kuning; pulau batam WV 29433 ; ID 29433
• Manufacturer (Section G): PT. CIBA VISION BATAM; beringin kav. #204 batamindo; industrial park muka kuning; pulau batam WV 29433 ; ID 29433
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 23368674
• Report Number: 1119421-2025-02767
• Device Sequence Number: 8916243
• Product Code: HQL
• UDI-Device Identifier: 00380652552547
• UDI-Public: (01)00380652552547(17)290928(11)240930(10)31581874
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2025

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 Model Number: MA60AC
• Device Catalogue Number: MA60AC.210
• Device Lot Number: 31581874
• 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: 10/01/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 11/27/2025
• Date Device Manufactured: 09/30/2024
• 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: UNKNOWN CARTRIDGE.; UNKNOWN HANDPIECE.
• Patient Sex: Unknown