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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was returned in the lens case.Viscoelastic was observed on the lens.One haptic was bent.The optic was fractured in the haptic insertion area of the bent haptic.The lens was cleaned with klrp for further evaluation.The lens has a scrape mark on the anterior surface near the edge.Product history records were reviewed, and documentation indicated the product met release criteria.No similar complaint and no non-conformance reported for the product lot/batch/serial under investigation.The product investigation could not identify a root cause for the reported scratch.The reported optic damage was observed.Haptic damage and haptic insertion area damage was also observed.The presence of the solution on the returned sample is evidence that the product was subjected to handling.Due to the presence of surgical solution, we are unable to verify that the damage was present before use.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that during the intraocular lens (iol) implant procedure, lens was opened and not used due to scratch on lens.The scratch on the lens prior to insertion.The lens was not inserted in eye.A new lens was opened and inserted.

• 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: 21343191
• Report Number: 9681121-2025-00013
• Device Sequence Number: 9003369
• Product Code: HQL
• UDI-Device Identifier: 00380652552608
• UDI-Public: (01)00380652552608(17)281003(11)231006(10)31560527
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/10/2025

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.240
• Device Lot Number: 31560527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2023
• 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