MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON ASPHERIC UV ABSORBING IOL WITH AUTONOME DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number	CCA0T0
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Retinal Detachment (2047)
Date of Event	03/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-healthcare professional reported that, after intraocular lens (iol) implantation surgery, on (b)(6) 2025, the patient was found to have a dislocated intraocular lens (iol) and a retinal detachment during the one-week post-operative visit.The patient was referred to a retina specialist.The visual acuity prognosis was discussed as unclear.The macula-off retinal detachment was surgically repaired on (b)(6) 2025.On (b)(6) 2025, the surgeon noted pupil capture and a dislocated iol.Surgical intervention was planned for synechiae release and iol repositioning if the haptics were in the bag or if unable to position complete lens in bag, an iol exchange was suggested to be performed.The lens was explanted and replaced with different model and diopter company lens in a secondary procedure on (b)(6) 2025.Additional information was requested.
Additional Manufacturer Narrative
Additional information was provided in d.9., h.3., h.6., and h.11.The product was returned for analysis.Iol (intraocular lens) was received cut in a half attached to a piece of paper inside a plastic bag.Solution is dried on the iol.No device returned.The root cause for the reported complaint could not be determined.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON ASPHERIC UV ABSORBING IOL WITH AUTONOME DELIVERY SYSTEM
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 23451403
• Report Number: 9612169-2025-02191
• Device Sequence Number: 12733747
• Product Code: HQL
• UDI-Device Identifier: 00380652397254
• UDI-Public: (01)00380652397254(17)271109(11)231111(10)25751224
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• 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,Followup
• Report Date (Section B): 01/08/2026

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: CCA0T0
• Device Lot Number: 25751224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/09/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2023
• 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: ACRYSOF MULTIPIECE IOL.; DUOVISC VISCOELASTIC SYSTEM.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male