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

Model Number	MA60MA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Blurred Vision (2137); Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that following an intraocular lens (iol) implant procedure, the patient experienced unresolved residual inflammation and no improvement in vision clarity.The iol was explanted due to hyperopic error and residual inflammation, with no improvement in vision.The explant occurred 2 months and 21 days after the initial implant procedure.Additional information was received that a non-company replacement lens was used and there was no further harm to the patient.In the surgeon's opinion, hyperopic error with residual inflammation and no improved clarity was because the patient was not tolerating the lens and it was not a device-related issue.The patient's issues were resolved, and the surgeon's prognosis was as expected to date.
Additional Manufacturer Narrative
Additional information was provided in h.3.And h.11.The product was not returned.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 non-qualified cartridge and viscoelastic were indicated with a qualified handpiece.The lens was explanted due to hyperopic error and residual inflammation with no improved vision.The root cause for reported hyperopic error and residual inflammation could not be determined.A malfunction has not been indicated against the lens.Each lens is subjected to a 100percentage assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.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: 23630599
• Report Number: 9681121-2025-00165
• Device Sequence Number: 21154862
• Product Code: HQL
• UDI-Device Identifier: 00380650699244
• UDI-Public: (01)00380650699244(17)280328(11)230331(10)31536683
• 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: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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: MA60MA
• Device Catalogue Number: MA60MA.010
• Device Lot Number: 31536683
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 02/20/2026
• Date Device Manufactured: 03/31/2023
• 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 PLUS OVD.; MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown