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

Model Number	MA60AC
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
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 the intraocular lens (iol) implant procedure, upon implanting the lens it was found to be defective.The lens was removed and replaced with new lens during the initial procedure.There was no patient harm reported.
Additional Manufacturer Narrative
The product was not returned.A photo was provided of the lens in the lens case base.There are marks observed in the center which may be damage.There was no similar complaint reported for the product lot/batch/serial under investigation.A non-conformance-based review did not reveal any potential contributing factors to the reported complaint.Product history records were reviewed and the documentation indicated the product met release criteria.The file indicates the use of a non-qualified cartridge.The company lens model is only qualified for use with the company cartridge.The root cause for the reported complaint is related to a failure to follow the(instructions for use) ifu.A non-qualified cartridge was indicated.The 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: 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 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: 19632971
• Report Number: 9681121-2024-00027
• Device Sequence Number: 8793382
• Product Code: HQL
• UDI-Device Identifier: 00380652552684
• UDI-Public: (01)00380652552684(17)270820(11)220822(10)31506457(21)31506457063
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2024

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.280
• Device Lot Number: 31506457
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 10/08/2024
• Date Device Manufactured: 08/22/2022
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Age: 65 YR
• Patient Sex: Female