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

Model Number	MA60AC
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/05/2025
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 health care professional reported with the description lens was faulty and was not implanted.
Additional Manufacturer Narrative
Additional information was provided in e.1., h.3., h.6.And h.11.The product was not returned.Photo was provided by reporter.Lens was shown anterior surface up in the lens case, positioned incorrectly.One haptic appeared to be bent-gusset area.Condition of the second haptic could not be observed due to the lens position.Unable to determine if there was viscoelastic on the lens.A device history record review and a non-conformance review of the reported lot number was conducted.No deviations were identified and all corresponding production release specifications defined in the device master record were met.Associated products were not provided.It is unknown if qualified products were used.The company lens model is only qualified for use in the company (a) and (b) cartridges.The specific issue was not provided.The provided photo shows one haptic appeared to be bent.A root cause could not be determined from the photo.Unable to determine if there was viscoelastic on the lens.It is difficult to make a determination of handling / damage without evaluation of the physical sample.A final root cause cannot be determined based on available information.Associated products were not provided.It is unknown if qualified associated products were used.The comapny lens model is only qualified for use in the company (a) and (b) cartridges.The instructions for use (ifu) 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: using holding forceps, 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 the optic is a little more than half-way inside the cartridge.Use the holding forceps to gently push down on the lens, verifying that the lens is on the bottom surface of the cartridge.Using holding forceps, take the trailing haptic, and gently fold the haptic onto the anterior side of the optic.Slowly grip or push the optic edge to position the lens as far into the cartridge as the forceps will permit, while ensuring the lens remains on the bottom surface of the cartridge and the trailing haptic remains on the optic.Failure to follow these steps may cause the lens to advance incorrectly causing delivery issues and/or damage.File will be reopened if new information or the sample 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: 22370429
• Report Number: 9681121-2025-00068
• Device Sequence Number: 8016810
• Product Code: HQL
• UDI-Device Identifier: 00380652552240
• UDI-Public: (01)00380652552240(17)280325(11)230328(10)31536668
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2025

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.060
• Device Lot Number: 31536668
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 09/01/2025
• Initial Report FDA Received Date: 07/01/2025
• Supplement Report FDA Received Date: 09/25/2025
• Date Device Manufactured: 03/28/2023
• 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
• Patient Sex: Unknown