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

Model Number	MTA4U0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vitreous Floaters (1866); Visual Impairment (2138); Visual Disturbances (2140); Eye Pain (4467)
Type of Reportable Event	Serious Injury
Event or Problem Description
A consumer reported experiencing unexpected visual outcomes following cataract surgery with intraocular lens (iol) implantation.She stated that the iol in her left eye had dislocated, that's why she had this lens placed as replacement.The new lens was placed behind her cornea, in front of her iris in the anterior chamber.She stated that during the surgery she was awake and heard the dr.Ask for "a size 4" to which he was told by staff that it was out of stock and only a "size 3" was available.She was unsure what this referred to.The patient had a history of ocular and retinal conditions unrelated to the cataract surgery.Postoperatively, she reported persistent soreness in the eye, significant light reflections that impair her ability to drive at night, and the presence of numerous floaters.She has been using an unspecified gel lubricant in the affected eye.Based on the additional information received, the patient had a follow-up appointment with her surgeon.However, the surgeon was unable to explain the cause of her sore eye, the presence of numerous floaters, or the extent of scattered light in her vision.The patient continues to experience eye pain and scattered light in her vision.She cannot see to drive at night, and daytime is not good either.She reports significant light sensitivity.To address her ongoing eye pain, she plans to consult a corneal specialist.Her next follow-up with the surgeon is scheduled in two months.
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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 section h.3., and h.11.Each lens is subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The reporter was the patient.Information was provided that the patient had prior ocular and retinal issues unrelated to the cataract surgery.The patient indicated the surgeon did not know why they were experiencing the reported issues.The patient queried what was meant by the surgeon¿s comments about the ¿4¿ and ¿3¿ lenses during their surgery.The "4" and "3" may have been referring to the polymethyl methacrylate (pmma) lens models overall length (size) category.The 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).The pmma "4" is designated for use with anterior chamber diameter 12.0-12.4 mm.The pmma "3" is designated for use with anterior chamber diameter 11.5-11.9 mm.Due diligence has been performed in an attempt to obtain further information on this event.The surgeon has not responded to requests for follow-up information.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: 23484599
• Report Number: 9681121-2025-00156
• Device Sequence Number: 10227972
• Product Code: HQL
• UDI-Device Identifier: 00380652535595
• UDI-Public: (01)00380652535595(17)300427(11)250429(10)31593554
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P880087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: MTA4U0
• Device Catalogue Number: MTA4U0.050
• Device Lot Number: 31593554
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/17/2025
• Supplement Date Received by Manufacturer: 01/18/2026
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 02/11/2026
• Date Device Manufactured: 04/29/2025
• 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: UNSPECIFIED GEL LUBRICANT
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 66 YR
• Patient Sex: Female