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

Model Number	MA60AC
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
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 registered nurse reported during intraocular lens (iol) implant procedure, the leading haptic was kinked.Occurred during surgery.There was no patient injury.No surgical intervention required.They opened new lens to complete surgery.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was not returned.A batch 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 batch record were met.The account indicated the use of a qualified associated cartridge with a non-qualified viscoelastic.The handpiece information was not provided.It is unknown if a qualified handpiece was used.The root cause for the reported complaint potentially related to a failure to follow the instructions for use (ifu).The viscoelastic indicated is not qualified for the lens/monarch combination used.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 handpiece information was not provided.It is unknown if a qualified handpiece was used.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: 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.Lenses with a 6.5 millimeter (mm) optic diameter may need to be pre-folded for easy entry into the back of the cartridge.Lens may be pre-folded by gently applying pressure to the edge of the lens while holding the central optic with forceps 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 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.Due diligence has been performed in an attempt to obtain further information on this event.File will be reopened if new information or product is received.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: 23901036
• Report Number: 9681121-2025-00201
• Device Sequence Number: 4989615
• Product Code: HQL
• UDI-Device Identifier: 00380652552523
• UDI-Public: (01)00380652552523(17)300323(11)250325(10)31592649
• 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
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2026

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.200
• Device Lot Number: 31592649
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 03/30/2026
• Date Device Manufactured: 03/25/2025
• 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.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Patient Age: 80 YR
• Patient Sex: Female