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

Model Number	CNWTT5
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	07/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported following an intraocular lens (iol) implant procedure, the toric intraocular lens (iol) had an incorrect axial position, leading to a suboptimal visual outcome.To address this issue and improve the uncorrected visual acuity, a surgical intervention was performed to rotate the intraocular lens to the correct position.Preoperative measurements: - uncorrected visual acuity (including date): date all over the gleiche: (b)(6) 2023: 0.32 decimal.- optimal corrected visual acuity (including date): 0,8 +.- manifest refraction (including date): +1,5 /-3,5/12.Postoperative measurements: - uncorrected visual acuity (including date): 0.4 decimal on (b)(6) 2023.- optimal corrected visual acuity (including date): 0.63 , (b)(6) 2023 - manifest refraction (including date): +0,75/-1,0/46 follow-up on 25-jul-2023: ucva 4m: 0.2 logmar, bcva 4m: 0.0 logmar.Subjective refraction: +0.75/-1.25/44°.Iol in loco, axis position should be: 84°, is 78°.
Additional Manufacturer Narrative
A sample device 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).
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON PANOPTIX TORIC TRIFOCAL HYDROPHOBIC 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: 17541408
• Report Number: 9612169-2023-00596
• Device Sequence Number: 6460490
• Product Code: MJP
• UDI-Device Identifier: 00380652469586
• UDI-Public: 00380652469586
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2023

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 Expiration Date: 02/01/2025
• Device Model Number: CNWTT5
• Device Catalogue Number: CNWTT5.195
• Device Lot Number: 25271512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2023
• Supplement Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 08/14/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2021
• 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: CLAREON MONARCH IV INJECTOR; MONARCH III, CARTRIDGE D
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male