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

Model Number	MA60AC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A health care professional reported a haptic defect in the intraocular lens (iol).Additional information was received on 22-feb-2026, providing further details about the reported event.The haptic broke inside the eye.Therefore, the lens was removed in an initial procedure.The patient is now aphakic in the right eye, with visual acuity documented as "hand motion perception".The patient has known history of zonular insufficiency.A sulcus implantation with 3-piece iol is scheduled for on (b)(6) 2026.Additional information has been requested but is not available at the time of this report.
Additional Manufacturer Narrative
Additional information provided in section b.5.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.
Event or Problem Description
According to the additional information received, the patient was left aphakic for approximately 21 days.On (b)(6) 2026, a lens of the same model, diopter, and company as the original was implanted in the sulcus.The patient is scheduled for follow-up.

• 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: 24518727
• Report Number: 9681121-2026-00038
• Device Sequence Number: 9724175
• Product Code: HQL
• UDI-Device Identifier: 00380652552592
• UDI-Public: (01)00380652552592(17)271023(11)221025(10)31516722
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/09/2026

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.235
• Device Lot Number: 31516722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2026
• Supplement Date Received by Manufacturer: 03/11/2026; 05/12/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 04/02/2026; 06/09/2026
• Date Device Manufactured: 10/25/2022
• 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: MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B.; SVISC 1,4%.
• Patient Age: 88 YR
• Patient Sex: Female