MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON TORIC IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CNW0T5
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
A surgeon reported that following a femtosecond-laser-assisted cataract surgery (flacs) and intraocular lens (iol) implant procedure in a high myope patient, next day (24 hours) surgeon found that the iol to be rotated by a good 40 degrees and at one week it remained similar.There was no history of any eye rubbing or trauma on the day of surgery.Surgeon advised an iol rotation to the patient.However, the patient was not keen on a second intraoperative intervention and was ok to wear whatever the final refraction was, although patient was not happy about it.Additional information has been was received and stated that patient was planned for 64 degree placement but after 24 hours of iol implantation had 48 degree rotation 2.00 diopter change in cylindrical.Th patient was willing to accept the glasses and was not keen on iol rotation.
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).
Additional Manufacturer Narrative
Additional information was provided in h.3., h.6.And h.11.The product was not returned for analysis.Only photo and video was returned.A provided video of the operative procedure along with a slide presentation including post-operative images were reviewed for a report of toric intraocular lens (iol) rotation.While it is difficult to know the exact alignment of the images relative to one another, the position of the toric markings at the at the completion of operative procedure compared to the images provided identified as 1 day follow up and 1 week follow up show a difference in alignment consistent with rotation as reported.The surgery was reported as uneventful, and no product quality issues were noted in the materials provided.A meeting has been scheduled with the surgeon and alcon clinical associates for further clinical outcomes discussions.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).
Event or Problem Description
Additional information received and stated, that the patient cylinder power which was intended to correct through toric iol was not been corrected because of the iol rotation and patient remain dependent on astigmatism corrective glasses.
Additional Manufacturer Narrative
Additional information was provided b.5.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON TORIC IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 21421784
• Report Number: 9612169-2025-00241
• Device Sequence Number: 7642404
• Product Code: MJP
• UDI-Device Identifier: 00380652410519
• UDI-Public: (01)00380652410519(17)270920(11)230922(10)25716675
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/25/2025

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: CNW0T5
• Device Lot Number: 25716675
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2025
• Supplement Date Received by Manufacturer: 03/04/2025; 06/30/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 04/01/2025; 07/25/2025
• Date Device Manufactured: 09/22/2023
• 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: ARGOS BIOMETER.; SURGICAL PRODUCT, UNSPECIFIED.; VERION REFERENCE UNIT.
• Patient Age: 61 YR
• Patient Sex: Male