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

Model Number	MA60AC
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A non-healthcare professional reported with the description of scratch on the intraocular lens.Additional information has been requested.
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).
Additional Manufacturer Narrative
Additional information has been provided in b.2., b.5., d.6.A., d.6.B, d.1.0., e.1 and h.3.
Event or Problem Description
Additional information has received and it states there was no issue with haptics.The main wound was extended to facilitate iol exchange.As result, the patient had increased surgically induced astigmatism.Hence increased topical steroidal medication to reduce the inflammation and surgical induced astigmatism.Lens was explanted and replaced with another lens during the initial procedure.
Additional Manufacturer Narrative
Additional information has been 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.No deviations were identified and all corresponding production release specifications defined in the device master record were met.A non-qualified viscoelastic was indicated.It is unknown if a qualified cartridge and handpiece were used.The company lens model is only qualified for use in the company (a) and (b) cartridges with a company ii or iii handpiece.The product investigation could not identify a root cause for the reported complaint.The product has not been received for evaluation.A non-qualified viscoelastic was indicated.It is unknown if a qualified cartridge and handpiece were used.The company model is only qualified for use in the company (a) and (b) cartridges with a company ii or iii handpiece.The ifu (instruction for use) instructs: company foldable iols (intraocular lens) 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.Follow up and due diligence have been performed.File will be reopened if new information or the sample 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: 22308478
• Report Number: 9681121-2025-00063
• Device Sequence Number: 15595449
• Product Code: HQL
• UDI-Device Identifier: 00380652552592
• UDI-Public: (01)00380652552592(17)290413(11)240415(10)31572314
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2025

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.235
• Device Lot Number: 31572314
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: 06/26/2025; 08/27/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 07/21/2025; 09/19/2025
• Date Device Manufactured: 04/15/2024
• 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: PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown