MAUDE Adverse Event Report: PT. CIBA VISION Batam AcrySof Multipiece IOL; Intraocular Lens

Model Number	MA60AC
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A non-health care professional reported that during an intraocular lens (iol) implantation procedure, surgeon observed haptic was bent and when inserted with the injector haptic ruptured.The procedure was completed on the same day.There was no contact between the patient and the device.Additional information has been received and stated haptic bent was observed in two lens, and optic tore was observed in one lens.There was harm 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.

• 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 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: 50898511
• Report Number: 9681121-2026-00298
• Device Sequence Number: 6001566
• Product Code: HQL
• UDI-Device Identifier: 00380652552578
• UDI-Public: (01)00380652552578(17)300723(11)250725(10)31601214
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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 Model Number: MA60AC
• Device Catalogue Number: MA60AC.225
• Device Lot Number: 31601214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 07/25/2025
• 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: AcrySof Multipiece IOL 1.; AcrySof Multipiece IOL 2; MONARCH II IOL, Cartridge B.; MONARCH IOL Injector, Unspecified.; UNSPECIFIED OVD.
• Patient Sex: Unknown