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

Model Number	MA60AC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
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 non-healthcare professional reported during an intraocular lens (iol) implant procedure, the intraocular lens was implanted using the cartridge it was found that one of the haptics had come loose from the lens.The lens was removed during initial procedure.Additional information has been received and stated that the surgery was completed with the replacement lens.There was no patient harm.
Additional Manufacturer Narrative
Additional information was provided in d.10., h.3., h.6.And h.11.A non-qualified cartridge and viscoelastic were indicated.It is unknown if a qualified handpiece was used.The company lens models is only qualified for use in the company cartridges.The root cause for the reported damage would be related to a failure to follow the ifu.A non-qualified cartridge and viscoelastic were 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 lens carton label and lens case label are designated with smallest qualified cartridge information.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: 21662531
• Report Number: 9681121-2025-00030
• Device Sequence Number: 15688522
• Product Code: HQL
• UDI-Device Identifier: 00380652552448
• UDI-Public: (01)00380652552448(17)290422(11)240424(10)31572893
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2025

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: MA60AC
• Device Catalogue Number: MA60AC.160
• Device Lot Number: 31572893
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/21/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 05/29/2025
• Date Device Manufactured: 04/24/2024
• 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: MONARCH II IOL , CARTRIDGE B; MONARCH III IOL , CARTRIDGE C.; VISCO ¿ METHYLCELLULOSE 2 PERCENT.
• Patient Age: 61 YR
• Patient Sex: Female