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 Codes	Vitreous Floaters (1866); Blurred Vision (2137); Visual Disturbances (2140); UGH (Uveitis Glaucoma Hyphema) Syndrome (4470)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A product was not returned for analysis.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).
Event or Problem Description
A non-healthcare professional reported that, after intraocular lens implantation surgery, the patient experienced constant floaters, blurred va and photophobia.Hence the lens was explanted and replaced with another lens in a secondary procedure.The clinical reason for explant was uveitis glaucoma hyphema.The patient also had a history of blunt trauma in the right eye prior to cataract surgery.Additional information was received stating that, in the surgeon's opinion, the lens was out of position and the optic caught in iris and the trauma prior to cataract surgery might have contributed to the event.After the explantation, the patient's condition was not completely resolved but it was much improved and the surgeon's prognosis was good.
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The lens was returned inside a small, plastic, specimen jar.Dried solution and reddish colored solution (possibly blood) was observed on the lens.One haptic was broken in the gusset area (not returned).The other haptic was broken in the distal area (not returned).The lens was cleaned with klrp to further evaluate.After removal of the dried solutions, one haptic posterior distal edge area was observed chipped.The optic posterior surface was cracked in the haptic/optic junction area.Another posterior cracked area was observed near the optic edge.The posterior optic edge was chipped at two small areas.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 product investigation could not determine the root cause for the reported complaint.The explanted lens was returned with haptic and optic damage.It is not possible to confirm the position of the lens while in the eye based on the physical evaluation of the returned, explanted lens.Information was provided that the patient had pre-existing ocular condition of trauma prior to initial cataract surgery.The 16.5 diopter lens was removed and replaced with a non-company lens, reported to be a 20.0 diopter lens.Due to the 16.5 diopter lens being exchanged for a lens that was 3.5 diopters larger, the replacement lens diopter may suggest that the replacement lens was an improved selection for this patient's vision needs.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: 23377765
• Report Number: 9681121-2025-00138
• Device Sequence Number: 9091386
• Product Code: HQL
• UDI-Device Identifier: 00380652535823
• UDI-Public: (01)00380652535823(17)260430(11)210531(10)31455626
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P880087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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 Expiration Date: 04/30/2026
• Device Model Number: MTA4U0
• Device Catalogue Number: MTA4U0.165
• Device Lot Number: 31455626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2021
• 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: AMVISC; LENSGLIDE
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male