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

Model Number	MA60MA
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
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 nurse reported with a description of intraocular lens was defective one of the haptics was bent.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was provided in b.3., d.10., b.5., h.6.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received and stated that the surgery was completed on the same day with another lens.There was no patient contact.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.A photo was provided by reporter.The photo only shows the carton of reported complaint lot.No determination could be made from the photo.The product was not returned.A device history record review and a non-conformance-based review of the lot was performed and did not reveal any potential contributing factors to the reported complaint.All corresponding production release specifications defined in the device master record were met.A qualified cartridge was indicated with a non-qualified handpiece.Two viscoelastics were indicated; only one is qualified for the lens/cartridge combination used.It is unknown which viscoelastic was used in the cartridge.The product was not returned for evaluation.The root cause for the reported complaint potentially related to a failure to follow the instructions for use (ifu).A qualified cartridge was indicated with a non qualified handpiece.The ifu instructs: company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that an 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.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.File will be reopened if new information or the 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: 22860707
• Report Number: 9681121-2025-00100
• Device Sequence Number: 13089665
• Product Code: HQL
• UDI-Device Identifier: 00380650699244
• UDI-Public: (01)00380650699244(17)290824(11)240826(10)31579985
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/18/2025

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: MA60MA
• Device Catalogue Number: MA60MA.010
• Device Lot Number: 31579985
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/02/2025
• Supplement Date Received by Manufacturer: 08/22/2025; 10/27/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 09/10/2025; 11/18/2025
• Date Device Manufactured: 08/26/2024
• 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: DUOVISC OVD; HANDPIECE: OZIL; MONARCH II IOL, CARTRIDGE B
• Patient Sex: Unknown