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

Model Number	MA60MA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	09/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported during intraocular lens (iol) implant procedure, posterior capsule was ruptured upon implantation.The lens was explanted and replaced with anterior chamber intraocular lens (aciol) during initial procedure.The procedure was completed on same day without any harm to the patient.As per surgeon it was unsure whether it was the lens or patient's eye anatomy but definitely not the surgeon factor.
Additional Manufacturer Narrative
A sample device 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 was provided in d.9., h.3., h.6.And h.11.The lens was returned in a lens case base.The lens case lid was not returned.A small amount of solution and gauze fibers were observed on the lens.One haptic was bent-gusset area.The lens was cleaned with klrp.Two small scratches were observed near the edge.The lens dimensions were acceptable using an approved template (excluding the damaged haptic).No similar complaint and no non-conformance reported for the product lot/batch/serial under investigation.Complaint and product history records were reviewed, and documentation indicated the product met release criteria.The file indicated the use of a qualified handpiece with a non-qualified cartridge and viscoelastic.The company lens is only qualified for use with the company specific model cartridge.The root cause for the reported posterior capsule rupture could not be determined.The lens was returned.The lens dimensions were acceptable (plan view) using an approved template (excluding the damage haptic).One haptic was bent and two small scratches were observed.The root cause for observed lens damage may be related to a failure to follow the instructions for use (ifu).The file indicated the use of a non-qualified cartridge and viscoelastic.The company is only qualified for use with the company specific model cartridge.The ifu instructs: company foldable intraocular lens (iols) are qualified for use with an 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 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: 20559227
• Report Number: 9681121-2024-00061
• Device Sequence Number: 11535256
• Product Code: HQL
• UDI-Device Identifier: 00380650699312
• UDI-Public: (01)00380650699312(17)271210(11)221212(10)31523080
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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
• Report Date (Section B): 01/17/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: MA60MA
• Device Catalogue Number: MA60MAN030
• Device Lot Number: 31523080
• 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: 09/30/2024
• Supplement Date Received by Manufacturer: 12/25/2024
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2022
• 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: DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE; MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; REPLACEMENT ACIOL
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Male