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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
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).
Event or Problem Description
A non healthcare professional reported during intraocular lens (iol) implant procedure, the trailing haptic broke off as surgeon was trying to pull out lens from company cartridge with no patient contact.The procedure was completed on same day with non company replacement lens.Additional information has been requested.
Event or Problem Description
Additional information was requested and received stating that the patient was scheduled for routine extraction of cataract with phacoemulsification and intraocular lens (iol) replacement.A company lens was chosen for in-the-bag implantation.From surgeon dictation, the lens was divided using the sculpt phacoemulsification setting when the entire lens suddenly dropped into the posterior pole, likely secondary to a posterior capsule rupture.A vitrectomy was performed.Lens choice was changed to a sulcus placement company lens, but it could not be loaded smoothly.The surgeon attempted to load the sulcus placement company lens into the company cartridge using the company lens pusher.The lens did not glide in smoothly, so the surgeon tried to reposition it again using the same pusher.While the surgeon pulled the lens out of the cartridge, the trailing haptic broke off.The lens remained in the delivery system and was unusable with no patient contact.The procedure was completed on the same day with a non-company replacement lens.In the surgeon's opinion, the lens not gliding smoothly inside the company cartridge caused or contributed to the event.The patient's issues were resolved, and the surgeon's prognosis was good.
Additional Manufacturer Narrative
Additional information was provided in b.5.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.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.The account indicated the use of a qualified associated cartridge and handpiece with a non-qualified viscoelastic.The product was not returned.The root cause for the reported event is related to a failure to follow the instruction for use (ifu).A non-qualified viscoelastic was indicated.The ifu instructs: company foldable intraocular lenses (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.Haptic manufacturing is a validated process with multiple inspections to verify the quality of the produced haptic material.These inspections include a verification of the dimensional accuracy, tensile strength, flexibility and cosmetic appearance.The inspections ensure that the material meets all required specifications before it is allocated for use.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: 22895460
• Report Number: 9681121-2025-00103
• Device Sequence Number: 8958070
• Product Code: HQL
• UDI-Device Identifier: 00380652552547
• UDI-Public: (01)00380652552547(17)290702(11)240704(10)31576854
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup,Followup
• Report Date (Section B): 11/19/2025

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: 31576854
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 09/11/2025; 11/02/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 10/02/2025; 11/19/2025
• Date Device Manufactured: 07/04/2024
• 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: MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B; MONARCH II LOADING FORCEPS; MONARCH II LOADING FORCEPS; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Age: 77 YR
• Patient Sex: Male