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 Code	Visual Impairment (2138)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician requested a +0.5 diopters (positive) lens but -0.5 diopters (negative) was processed by mistake and it was implanted to the patient.The error was also not detected, affecting the patient's vision, and the problem was detected.Hence the lens was explanted in the secondary procedure and the correct company lens was implanted.The replacement surgery was performed without incident and the patient issue was resolved.
Additional Manufacturer Narrative
A 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).
Additional Manufacturer Narrative
Additional information has been provided in h.3., h.6., and h.11.The product was not returned.There is no similar complaint reported under lot 31585761.A device history record review and a non-conformance review of the reported lot number was conducted.No deviations were identified and all corresponding production release specifications defined in the device master record were met.All lenses had passed the power and resolution inspection.The power of reported lot# is correctly -5.0 d.The product was not returned.The complaint event was not related to the manufacturing facility.The reporting hospital indicated to receive company lens with -5.0 d, while they requested +5.0 d.The root cause of this event is due to miscommunication between hospital and company customer service (outside of manufacturing site).An incident had been summarized by customer service team.Based on the summary, on september 29, 2025, the hospital submitted urgent order for lens with 050 diopter which then confirmed by company reviewing order number.Subsequently, the hospital rejected the lens and requested a negative diopter.However, the original po indicated the need for a +5.0 d lens, not a negative one.From company side, both lenses were shipped: the lens 050 diopter, which was rejected, and later the lens with 050 diopter, which was sent due to a misunderstanding of the hospital's needs based on the back-and-forth communication.No abnormalities and discrepancy in manufacturing process of lot was detected.All lenses already passed the power and resolution inspection.All products are labelled with correct product information.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: 23391058
• Report Number: 9681121-2025-00144
• Device Sequence Number: 15964395
• Product Code: HQL
• UDI-Device Identifier: 00380650699336
• UDI-Public: (01)00380650699336(17)291203(11)241205(10)31585761
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2025

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: MA60MA
• Device Catalogue Number: MA60MAN050
• Device Lot Number: 31585761
• 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: 10/03/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 11/25/2025
• Date Device Manufactured: 12/05/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female