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

Model Number	MTA4U0
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A non¿health care professional reported that after an intraocular lens (iol) implantation procedure, the iol was dislocated.The clinical reason provided for explantation was mechanical breakdown iol dislocation.No replacement lens was implanted, and the patient was left aphakic.Additional information has been requested.
Additional Manufacturer Narrative
The lens was returned on a piece of sponge wrapped in gauze.Solution was observed on the lens.The lens was cleaned with klotho-related protein (klrp).No damage was observed.The lens dimensions were acceptable (plan view) using an approved template.A batch 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 batch record were met.The root cause could not be determined for the reported intraocular lens (iol) dislocation.No problem was found with returned lens.No damage was observed.The lens met dimensional specification (plan view).The poly methyl methacrylate (pmma) single-piece anterior chamber intraocular lens (iol) is an optical implant designed to be positioned anterior to the iris.The lens should replace the optical function (but not the accommodation) of the natural crystalline lens.The physical properties of these lenses as well as the sizing guidance for these anterior chamber lenses is provided in the instructions for use (ifu).Sizing guidance is provided in the instructions for use (ifu).The company is designated for use with anterior chamber diameter 12.0-12.4.Information provided indicated the lens was implanted on (b)(6) 2025 and explanted on (b)(6) 2025.The patient was left aphakic.No information was provided why another lens was not implanted.The manufacturer internal reference number is: (b)(4).

• 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: 25186300
• Report Number: 9681121-2026-00120
• Device Sequence Number: 18816920
• Product Code: HQL
• UDI-Device Identifier: 00380652535816
• UDI-Public: (01)00380652535816(17)270831(11)220902(10)31508851
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P880087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MTA4U0
• Device Catalogue Number: MTA4U0.160
• Device Lot Number: 31508851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2022
• 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: PROVISC OVD.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male