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	Insufficient Information (4580)
Date of Event	08/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported with a description of haptic torn off.Additional information received stating that event occurred during surgery and there was patient contact.Procedure was completed with backup product.The procedure was 5 minutes delayed due to the event.In the surgeon's opinion, adhesive joint between bow and haptic loose contributed to the event.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The lens was returned in the lens case.Viscoelastic and fibers were observed dried on both sides of the optic.One haptic was broken with a portion retained in the haptic insertion area.The lens was cleaned with klrp for further evaluation.The lens had a long scratch across the center of the anterior optic surface with a cracked area at the end of the scratch.The optic was also cracked on the posterior surface in the same area.This damage may indicate a plunger over/underride occurred.The optic also has a narrow, angled scratch on the anterior surface that was similar in appearance to damage caused by an instrument used to grasp the lens (forceps).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.It is unknown of a qualified handpiece was used.The lens was returned.No issues were observed with the laser weld of the haptic.The haptic was broken.Optic damage was also observed, which may indicate a plunger override occurred.The root cause for the damage may be related to a failure to follow the instructions for use (ifu).A non-qualified viscoelastic was used.It is unknown if a qualified handpiece was used.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.Important: the plunger should make initial contact with the cartridge at the ramp.In the event the plunger does not contact the cartridge at the ramp, do not use the handpiece and contact company.The handpiece ifu instructs: verify that the plunger tip is properly engaging the lens optic and that the lens moves forward at the same rate as the plunger while slowly advancing the plunger forward to avoid damaging the lens.When the threads on the knob make contact with the barrel, turn the knob clockwise approximately half turn to engage the threads and then stop.The iol will now be in the dwell position.Inspect to ensure the plunger is behind the optic.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: 23096015
• Report Number: 9681121-2025-00116
• Device Sequence Number: 21004071
• Product Code: HQL
• UDI-Device Identifier: 00380652552622
• UDI-Public: (01)00380652552622(17)290624(11)240626(10)31576439
• 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
• Report Date (Section B): 10/22/2025

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.250
• Device Lot Number: 31576439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/28/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2024
• 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: METHOCEL.; MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B.; UNSPECIFIED INJECTOR.
• Patient Age: 56 YR
• Patient Sex: Male