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

Model Number	MA60AC
Medical Device Problem Codes	Failure to Deliver (2338); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/09/2025
Type of Reportable Event	Serious Injury
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).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 that intraocular lens implant procedure, the physician schedule capsulometresis and phacoemulsification with chop technique during implanting the lens stuck in injector and haptic was twisted.The lens of same model was used but again the lens was stuck and haptic was damaged.The patient was left aphakic.Posterior vitrectomy was performed.Additional information has been requested.
Additional Manufacturer Narrative
Additional information provided in d.9., d.10, h.3., h.6.And h.11.The lens was returned positioned incorrectly in the lens case.Viscoelastic was dried on the lens and outside the well area of the lens case.One haptic was bent in the distal area with the distal portion extended down into a drain hole of the lens case.One side of the optic was tilted down into the well area of the lens case with the optic edge pressed against the wall of the inner well.A device history record review and a non-conformance review of the reported lot number was conducted.No deviations were identified and all corresponding production release specifications defined in the device master record were met.The associated cartridge and handpiece information was not provided.The company model is only qualified for use in the company cartridges with a qualified handpiece.It is unknown if a qualified cartridge and handpiece were used.Two viscoelastic were indicated.One of the viscoelastic is not qualified for use with this lens when used with any qualified associated cartridge and handpiece combinations.Only the lens was returned.Bent haptic damage was observed.The root cause for the reported complaint may be related to a failure to follow the (instructions for use) ifu.A non-qualified viscoelastic was indicated.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.Lenses with a 6.5 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 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 company diopter lens for this file was indicated to be the initial lens.A back up lens (company 27.5 diopter) was selected.Specific clarification was not provided for the selection of a back up lens with a difference of 1.5 diopters.Damage to the haptic was also reported during the use of the back up lens.The patient was left aphakic.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: 22705212
• Report Number: 9681121-2025-00084
• Device Sequence Number: 15712735
• Product Code: HQL
• UDI-Device Identifier: 00380652552707
• UDI-Public: (01)00380652552707(17)280730(11)230802(10)31550988
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 09/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.290
• Device Lot Number: 31550988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2023
• 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: LIDOCAINE; PROVISC; UNSPECIFIED INJECTOR; VISCOAT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown