MAUDE Adverse Event Report: Alcon Laboratories Ireland Ltd. Clareon IOL with the AutonoME Delivery System; Intraocular Lens

Model Number	CNA0T0
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that, during an intraocular lens (iol) implantation procedure, after implantation a scratch was noticed on the surface of the lens.Therefore, the lens was cut in half using scissors and explanted (removed).Additional information has been requested and received it states that implanted the iol into the eye in the usual manner.At the moment the iol unfolded (and the optic could be seen in its entirety), a small tear became visible at the edge of the optic.To allow for immediate explantation, physician divided the iol into two halves with scissors and then removed both halves from the eye.Subsequently, the surgeon was able to implant a new iol of the same type without any harm to the patient.
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).

• Brand Name: Clareon IOL with the 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 ; +1(800)757-9780
• MDR Report Key: 50788448
• Report Number: 9612169-2026-02089
• Device Sequence Number: 9443009
• Product Code: HQL
• UDI-Device Identifier: 00380652393720
• UDI-Public: (01)00380652393720(17)290603(11)260605(10)26272695
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2026

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: CNA0T0
• Device Lot Number: 26272695
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/16/2026
• Date Device Manufactured: 06/05/2026
• 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.; Unspecified scissors.
• Patient Age: 71 YR
• Patient Sex: Female