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

Model Number	MA60MA
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported that during an intraocular lens (iol) implant procedure, the lens was implanted, then doctor decided to cut it out.Lens would not opened up like it was supposed to.The procedure was completed on the same day with company lens of same model and diopter.There was no patient harm.
Additional Manufacturer Narrative
Lens was returned posterior up in the lens case, positioned incorrectly in well area and pressed against the posts.Viscoelastic was observed on both sides of the lens.The lens was cut into three pieces typical of removal and adhered to one another by the viscoelastic.One haptic was bent-distal area.The edge side of the optic near the bent haptic was pressed against a post of the lens case.Product history records were reviewed, and documentation indicated the product met release criteria.A qualified associated cartridge was identified.A non-qualified handpiece and viscoelastic were indicated.This company lens is only qualified for use with the company (a) cartridges; and company ii and iii handpiece.The root cause for the lens wouldn't open up is most likely related to a failure to follow the instructions for use (ifu).A non-qualified handpiece and viscoelastic were indicated.This company lens is only qualified for use with the company (a) cartridges; and company ii and iii handpiece.One haptic was bent-distal area.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.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.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: 22495348
• Report Number: 9681121-2025-00073
• Device Sequence Number: 18127827
• Product Code: HQL
• UDI-Device Identifier: 00380650699336
• UDI-Public: (01)00380650699336(17)290525(11)240527(10)31574678
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/14/2025

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: MA60MA
• Device Catalogue Number: MA60MAN050
• Device Lot Number: 31574678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2024
• 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: CLAREON MONARCH IV IOL DELIVERY SYSTEM; MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE A; MONARCH II LOADING FORCEPS; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Sex: Unknown