MAUDE Adverse Event Report: PT. CIBA VISION BATAM ANTERIOR CHAMBER PMMA SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	MTA4U0
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was returned anterior surface up the lens case.A small amount of solution was dried on the lens and remaining haptic.One haptic was broken-gusset area (not returned).A 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 reported haptic damage was observed.The product investigation could not identify a root cause for the broken haptic.The observed haptic damage was similar in appearance to handling related.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 when opened.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non health care professional reported that during the intraocular lens (iol) implant procedure lens found to be faulty.Only one handle/arm on lens.The procedure was completed on the same day.Additional information has been requested.

• Brand Name: ANTERIOR CHAMBER PMMA SINGLEPIECE 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: 23672017
• Report Number: 9681121-2025-00172
• Device Sequence Number: 9984545
• Product Code: HQL
• UDI-Device Identifier: 00380652535755
• UDI-Public: (01)00380652535755(17)290211(11)240214(10)31568998
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P880087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/28/2025

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: MTA4U0
• Device Catalogue Number: MTA4U0.130
• Device Lot Number: 31568998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 11/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN CARTRIDGE.; UNKNOWN INJECTOR/HANDPIECE.; UNKNOWN VISCOELASTIC.
• Patient Sex: Unknown