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

Model Number	MA60AC
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was returned advanced to the nozzle entry area of a company cartridge.Viscoelastic was observed in the cartridge.The trailing haptic was bent-distal area.The cartridge had evidence of placement into a handpiece.The used company cartridge was cleaned for further evaluation.The lens was removed during cleaning.Topcoat dye stain testing was conducted with acceptable result.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 was used.It is unknown if a qualified handpiece and viscoelastic were used.The lens was returned inside a qualified cartridge.The trailing haptic was bent-distal area.The root cause for the haptic damage cannot be determined.It is unknown if a qualified handpiece and viscoelastic were used.The instructions for use (ifu) instructs: company foldable iols are qualified for use with a company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that a company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.The ifu instructs: use holding forceps to grasp the lens by the optic edge and gently place the lens anterior side up into the back of the ovd-filled cartridge.The lens should be inserted until it is centered with or slightly past the outline etched into the top of the cartridge.The trailing haptic will extend from the proximal end of the cartridge.Position the trailing haptic to the left of the haptic post as shown in the detailed view.This will allow the plunger to go past the haptic during the initial advancement of the plunger into the cartridge.Verify the lens is positioned on the bottom surface of the cartridge.The haptic should be maintained to the left of the post when the lens is loaded correctly.Accurate positioning of the lens will decrease the potential for optic and haptic damage.No issue was found with the returned cartridge.Topcoat dye stain testing was conducted with acceptable results.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that during the intraocular lens (iol) implant procedure, lens damaged when implanting.

• 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: 23278096
• Report Number: 9681121-2025-00127
• Device Sequence Number: 8736985
• Product Code: HQL
• UDI-Device Identifier: 00380652552547
• UDI-Public: (01)00380652552547(17)280903(11)230906(10)31557522
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/13/2025

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.210
• Device Lot Number: 31557522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2023
• 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: MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B
• Patient Sex: Unknown