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

Model Number	CNW0T6
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138)
Type of Reportable Event	Malfunction
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 consumer (who is also a physician) reported that following an intraocular lens (iol) implant procedure the patient had experienced eye toric power was still very high / not corrected after the company toric intraocular lens (iol) implant.Additional information has been received stating symptoms started appearing after 1 week and continued after 3 weeks, as vision check found no improvement in terms of cylindrical power and axis.The patient had cylindrical power and axis in spite of using company toric intraocular lens (iol) and readability of letters was not good due to blurred letters.Vision quality was also not much improved as sharpness, contrast of pictures were still not good.Eye care provider not commented as such why toric power iol failed to correct cylindrical power and axis.As per eye care provider problems related to picture quality may be due to other eye issues.Additional information has been received from physician stating that patient came for follow up 3-4 times.The physician confirmed that patient was well advised about the power correction after surgery.The patient did not complaint of residual spectacle in the left eye.Before surgery patient requested to correct more near vision and he was ok if distant vision residual power was persisted post operation.Additional information received from consumer stating as per doctor iol (intra ocular lens) was found at different axis as it rotated inside eye and did not help correction of cylindrical power.Additional information received from consumer stating doctor checked the axis of iol on (b)(6) 2024 and confirmed that iol found rotated more 10 deg from desired axis.

• 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: 20799334
• Report Number: 9612169-2024-01227
• Device Sequence Number: 6726732
• Product Code: MJP
• UDI-Device Identifier: 00380652411127
• UDI-Public: (01)00380652411127(17)261120(11)221122(10)25537562
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/27/2024

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: CNW0T6
• Device Lot Number: 25537562
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 11/27/2024
• Date Device Manufactured: 11/22/2022
• 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
• Patient Age: 59 YR
• Patient Sex: Male