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

Model Number	MA60AC
Medical Device Problem Codes	Break (1069); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported that during cataract surgery with intraocular lens (iol) implantation, the surgeon had found that the upon injection upper haptic fractured, as the lower haptic did not fully enter the injector.The patient was not affected, as the fracture had been identified in time before implantation, and the surgery was completed on the same day.Additional information has been requested.
Additional Manufacturer Narrative
Corrected information provided in h.6.Additional information was provided in h.3., h.6.And h.11.The intraocular lens (iol) was returned in the qualified company ii (b) cartridge.Viscoelastic was observed in the cartridge.The iol was at the nozzle entry area folded correctly.The broken tip of the leading haptic was observed at the end of the cartridge tip.This portion was also bent.This may indicate a plunger override occurred.The cartridge did not have evidence of being fully seated in a handpiece.This may have caused the plunger to be misaligned during advancement.The company ii (b) cartridge was cleaned for further evaluation.The iol was removed during cleaning.Topcoat dye stain testing was conducted with acceptable results.The returned product matched the provided photos.Qualified associated products were indicated.Complaint history and product history records were reviewed, and documentation indicated the product met release criteria.The root cause for the haptic fractured could not be determined.The position of the broken and bent leading haptic tip at the end of the cartridge with the iol at the nozzle entry area may indicate a plunger override occurred.The cartridge did not appear to have been fully seated in a handpiece.This may have caused the plunger to be misaligned when advancing.The instruction for use (ifu) instructs to slide the cartridge fully forward into the handpiece slot until it is secured firmly into position.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: 22586460
• Report Number: 9681121-2025-00077
• Device Sequence Number: 4565279
• Product Code: HQL
• UDI-Device Identifier: 00380652552509
• UDI-Public: (01)00380652552509(17)290330(11)240401(10)31571974
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2025

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.190
• Device Lot Number: 31571974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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: DUOVISC VISCOELASTIC SYSTEM; MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Patient Sex: Unknown