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

Model Number	MA60AC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vitreous Floaters (1866); Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Event or Problem Description
A facility representative reported following an intraocular lens (iol) implant procedure, the patient experienced multiple visual disturbances following implantation of the secondary iol on (b)(6) 2023, including cloudy vision, fluctuating near vision, floaters, and progressive blurry vision with decreased os vision despite prk enhancement.Persistent dissatisfaction and lack of improvement led to the decision to explant the company lens and replace it with another brand on (b)(6) 2025.No additional complications were reported during the exchange procedure.Additional information was requested.
Additional Manufacturer Narrative
Only one half of the lens was returned on a surgical sponge inside a biohazard bag.Viscoelastic was observed on the lens.The optic had been cut across the center, typical of removal.Power and resolution could not be reverified due to the optic damage.A device history record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the device master record were met.A qualified cartridge and handpiece were indicated with a non-qualified viscoelastic.The viscoelastic would not be a contributing factor for this complaint.The product investigation could not identify a root cause for the reported visual complaints.Only half of the lens was returned.The power and resolution couldn't be reverified due to the optic damage.Each lens is subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Information was provided that the patient had prior lasik in 2001.The patient had an unknown lens implanted in 2021.This complaint lens was the second os lens implanted (b)(6) 2023.Two weeks po patient had reported cloudy vision; distance was tolerable but near vision fluctuated through the day.The company lens is a monofocal lens, which corrects for one distance, near or far, as targeted by the surgeon.On (b)(6) 2025 the patient reported os blurry and a decrease in os vision overall.On (b)(6) 2025 patient received another prk.The lens was replaced with a non-company iol (b)(6) 2025.The model and diopter were not provided.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 ; 8007579780
• MDR Report Key: 23876316
• Report Number: 9681121-2025-00199
• Device Sequence Number: 4669077
• Product Code: HQL
• UDI-Device Identifier: 00380652552387
• UDI-Public: (01)00380652552387(17)271220(11)221222(10)31524548
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/23/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.130
• Device Lot Number: 31524548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/22/2022
• 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: AMVISC OVD; MONARCH II IOL CARTRIDGE B; MONARCH III IOL INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male