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	11/07/2024
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 healthcare professional reported that during intraocular lens (iol) implant procedure, haptic broke during lens loading.The procedure was completed on same day.There was no patient contact.Additional information received stating that trailing haptic broke.The surgery was completed by using alternative lens.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The lens was returned placed into the loading area of a qualified company ii (b) cartridge.Inadequate viscoelastic was observed in the cartridge.The trailing haptic was broken with a portion still retained in the insertion area.The optic was cracked across the insertion area and on the edge.The company ii (b) cartridge had not been placed into a handpiece.The cartridge was cleaned for further evaluation.Topcoat dye stain testing was conducted with acceptable results.All product and batch history records are quality reviewed prior to product release.No similar complaint and no non-conformance reported for the product lot/batch/serial under investigation.The file indicated the use of a qualified cartridge and handpiece combination.A non-qualified viscoelastic was indicated.The root cause for the reported trailing haptic damage appeared to have been caused by a failure to follow the instructions for use (ifu).The issue occurred upon initial insertion of the lens into the loading area.The haptic and optic were damaged.Inadequate viscoelastic was observed in the cartridge.In addition, a non-qualified viscoelastic was indicated.The ifu instructs that a company qualified delivery system and viscoelastic combination should be used.The use of a non-qualified combination may cause damage to the lens and potential complications during the implantation process.The ifu instructs to completely fill the cartridge with ophthalmic viscosurgical devices (ovd) immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.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.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: 20911621
• Report Number: 9681121-2024-00070
• Device Sequence Number: 8466008
• Product Code: HQL
• UDI-Device Identifier: 00380652552431
• UDI-Public: (01)00380652552431(17)270614(11)220616(10)31497323
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2025

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.155
• Device Lot Number: 31497323
• 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: 11/14/2024
• Supplement Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2022
• 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: HEALON VISCOELASTIC; MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B; MONARCH II IOL DELIVERY SYSTEM, INJECTOR
• Patient Sex: Unknown