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)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A pharmacist reported with a description, the lens was scratched.Additional information was received and stated, the incident occurred during preparation before injection and there was no patient contact.
Additional Manufacturer Narrative
The lens was returned posterior surface up in the lens case.Viscoelastic was dried on both sides of the lens.The lens was cleaned with klotho-related protein (klrp) for further evaluation.A narrow scratch was observed on the anterior optic surface.The scratch originated at the edge and travelled inward.This scratch was similar in appearance to a scratch caused by an instrument used to grasp the lens (forceps).A small crack was observed at the optic edge on both sides shaped like forceps.Device history record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the device master record were met.The root cause for the reported scratch appears to be related to user handling.A narrow scratch was observed on the anterior optic surface.The scratch originated at the edge and travelled inward.This scratch was similar in appearance to a scratch caused by an instrument used to grasp the lens (forceps).A small crack was observed at the optic edge on both sides shaped like forceps.All lenses are 100% inspected for cosmetic attributes, and the observed scratch would not have met company release criteria.Based on observation, and the review of manufacturing records, it is concluded that the damage is not manufacturing related.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely related to customer handling.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: 24256798
• Report Number: 9681121-2026-00015
• Device Sequence Number: 20910209
• Product Code: HQL
• UDI-Device Identifier: 00380652552509
• UDI-Public: (01)00380652552509(17)290930(11)241002(10)31582041
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 02/04/2026

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.190
• Device Lot Number: 31582041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 02/04/2026
• Date Device Manufactured: 10/02/2024
• 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
• Patient Sex: Unknown