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)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported that during an intraocular lens (iol) implantation procedure, upon attempting to implant the lens, it was observed that the haptic was bent.The surgery was completed on the same day using another unspecified lens without any harm.Additional information was requested and received, stating that no cartridge or injector was used because it was a keratoplasty with keratoprosthesis.Therefore, a lens that had been implanted in the patient for many years was removed, and the lens in question was inserted.The lens went directly from the packaging into the patient's eye.
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: 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: 50770946
• Report Number: 9681121-2026-00282
• Device Sequence Number: 18781971
• Product Code: HQL
• UDI-Device Identifier: 00380652552585
• UDI-Public: (01)00380652552585(17)300901(11)250903(10)31604553
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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.230
• Device Lot Number: 31604553
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 09/15/2026
• Date Device Manufactured: 09/03/2025
• 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: DISCOVISC Ophthalmic ViscoSurgical Device; Hyluron; PROVISC Ophthalmic ViscoSurgical Device; VISCOAT Ophthalmic ViscoSurgical Device
• Patient Age: 81 YR
• Patient Sex: Female