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

Model Number	MA60AC
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
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 doctor reported that he noticed paracentral axis latch in the iol after implantation of it and it was necessary to perform the exchange on the same day.No patient harm to the patient.Additional information has been requested and clarification received stating that the reported term was paracentral axis crack.
Additional Manufacturer Narrative
Additional information has been provided in d.10.,h.3., h.6., and h.11.The product was not returned.A photo was provided.The photo showed the back of the non-qualified company cartridge pouch.The photo also showed the lens carton endcap with the product information.The qualified cartridge is indicated on the carton label.The iol and company cartridge were not shown.Product history records were reviewed and documentation indicated the product met release criteria.A non-qualified cartridge and viscoelastic were indicated.The company lens is only qualified for use with the company ii (a) and (b) cartridges.The sample was indicated not available.The root cause for the reported damage is related to a failure to follow the ifu.A non-qualified cartridge and viscoelastic were indicated.The company lens is only qualified for use with the company ii (a) and (b) cartridges.The qualified cartridge is indicated on the carton endcap label and the lens case label.The ifu instructs: company foldable iols are qualified for use with a 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.File will be reopened if new information 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: 22124402
• Report Number: 9681121-2025-00053
• Device Sequence Number: 7505719
• Product Code: HQL
• UDI-Device Identifier: 00380652552523
• UDI-Public: (01)00380652552523(17)290703(11)240705(10)31576962
• 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,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

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: MA60AC
• Device Catalogue Number: MA60AC.200
• Device Lot Number: 31576962
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 07/18/2025
• Date Device Manufactured: 07/05/2024
• 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 III IOL, CARTRIDGE C.; MONARCH IOL, INJECTOR, UNSPECIFIED.; Z-HYALIN (VISCOELASTIC) / LOT: 10351CB.
• Patient Sex: Male