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

Model Number	MA60AC
Medical Device Problem Codes	Break (1069); Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
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 account manager reported that during an intraocular lens (iol) implant procedure, at the time of insertion the lens, haptic was broken at the time the lens exit from the cartridge, haptic remained attached to optic body of the lens.After multiple attempts surgeon was able to detach the haptic from the optic.There was no patient contact and patient harm.The procedure completed on the same day.Additional information was requested.
Additional Manufacturer Narrative
Additional information was provided in b.5., h.3., h.6.And h.11.The lens was returned positioned incorrectly in the lens case inside the carton.Viscoelastic was dried on the lens.One haptic was broken with a portion retained in the haptic insertion area.This haptic was not returned.The optic was broken on the edge against a post of the lens case due to the returned position of the lens.A device history record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the device master record were met.Associated products were not provided.It is unknown if qualified associated products were used.The company lens is only qualified for use with the company cartridge and company other model cartridges.The broken haptic was observed.The root cause of the broken haptic could not be determined.It is unknown if qualified associated products were used.The company lens is only qualified for use with the company cartridge and company other model cartridges.The ifu (instructions for use) 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 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).
Event or Problem Description
Additional information was received stating haptic was detected broken at the time was exit from the cartridge.

• 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: 22803878
• Report Number: 9681121-2025-00094
• Device Sequence Number: 18056614
• Product Code: HQL
• UDI-Device Identifier: 00380652552585
• UDI-Public: (01)00380652552585(17)280424(11)230427(10)31538688
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2025

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.230
• Device Lot Number: 31538688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 09/26/2025
• Date Device Manufactured: 04/27/2023
• 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 CARTRIDGE B.; MONARCH III INJECTOR.; PROVISC.
• Patient Sex: Unknown