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

Model Number	MA60AC
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported with a description of scratched intraocular lens (iol).Additional information has been requested.
Additional Manufacturer Narrative
A sample device 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).
Additional Manufacturer Narrative
Additional information provided in a.1., a.2., a.3., b.3., b.5., e.1., h.6.And h.10.The product was not returned.There is photo provided by reporter showing one opened lens inside unoriginal pack (vial) and one secondary pack of reported complained lot.Condition of lens could not be assessed from the provided photo to confirm this event.Product history records were reviewed, and documentation indicated the product met release criteria.The product investigation could not identify a root cause for the reported complaint.The product was not returned, and condition of lens could not be assessed from the provided photo.The instructions for use (ifu) instructs: company foldable intra ocular lenses (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 iol and potential complications during the implantation process.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been requested, received and stated the iol was explanted during initial procedure.There was no patient harm.

• 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: 17451886
• Report Number: 9681121-2023-00012
• Device Sequence Number: 20655091
• Product Code: HQL
• UDI-Device Identifier: 00380652552608
• UDI-Public: 00380652552608
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2023

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.240
• Device Lot Number: 31521663
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2022
• 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 II IOL CARTRIDGE B
• Patient Age: 54 YR
• Patient Sex: Female