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

Model Number	MA50BM
Medical Device Problem Codes	Break (1069); Failure to Deliver (2338)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A sample device 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 pharmacist reported that during an intraocular lens (iol) implant procedure, the surgeon made several injection attempts.However, the implant became stuck inside the cartridge, and one of the haptics broke.The procedure was completed with same model and diopter company lens.Additional information has been requested, received and stated the issue occurred during the progression of implant in the cartridge.Lens/injector touched the patient's eye.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.The lens was returned in the lens case.Viscoelastic was observed dried on both sides of the lens.One haptic was broken with a portion retained in the haptic insertion area, broken portion not returned.The other haptic was bent-gusset area.The lens was cleaned with klrp for further evaluation.The optic had two narrow scratch/gouges on the anterior surface near the edges.Multiple, lighter, scratches/scuffs were observed on the posterior and anterior surface of the optic.It was indicated the lens was loaded multiple times.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 indicated with a non-qualified viscoelastic.The handpiece model was not provided.It is unknown a qualified handpiece was used.The root cause for the reported issues may be related to a failure to follow the instructions for use (ifu).A non-qualified viscoelastic was indicated.It is unknown a qualified handpiece was used.The lens was not returned in the reported ¿stuck in the cartridge¿.The lens was returned in the lens case.The broken haptic was observed.Two narrow gouges were observed on the anterior surface.Scratches were observed on both surfaces.This damage was similar in appearance to damage caused by loading forceps.It was indicated that that the lens was loaded multiple times.The 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 to completely fill the cartridge with ovd immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.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.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.

• 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: 23716509
• Report Number: 9681121-2025-00180
• Device Sequence Number: 8901390
• Product Code: HQL
• UDI-Device Identifier: 00380650698575
• UDI-Public: (01)00380650698575(17)290306(11)240308(10)31570571
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2026

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: MA50BM
• Device Catalogue Number: MA50BM.220
• Device Lot Number: 31570571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMVISC.; MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE A.; MONARCH IOL DELIVERY SYSTEM, INJECTOR, UNSPECIFIED.
• Patient Sex: Unknown