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

Model Number	CNW0T5
Medical Device Problem Codes	Scratched Material (3020); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Visual Disturbances (2140); Halo (2227)
Date of Event	07/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health care professional reported that during an intraocular lens (iol) implant procedure, after implantation of an iol in the bag a scratch was found in the iol.The lens implantation was set up by a supporting doctor, so the surgeon did not see the iol setting process.During implantation he/she felt resistance a bit.Then he/she realized that there was a scratch in the iol.Since the iol was implanted in the bag accurately, considering the risk of decreased visual acuity the surgery was completed by rotating the iol 180 degrees while still in the patient's eye, so that the scratched part was facing upward (towards the patient's head).The patient felt like halo only for this eye and the surgeon thought that this might be due to the scratch of iol and the patient was planned to be monitored.
Additional Manufacturer Narrative
The product was not returned for analysis.The root cause for the reported complaint could not be determined as no sample was returned for analysis.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 was received and stated there was no problem with the injector and it was considered that it was a lens setting issue.At the next day's visit the patient complained of dazzling, but he said that there were no vision problems on later visits.

• 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: 20025992
• Report Number: 9612169-2024-00816
• Device Sequence Number: 8591040
• Product Code: MJP
• UDI-Device Identifier: 00380652410717
• UDI-Public: (01)00380652410717(17)270708(11)230710(10)25677054
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2024

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: CNW0T5
• Device Lot Number: 25677054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/25/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/20/2024
• Date Device Manufactured: 07/10/2023
• 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: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D.; MONARCH III IOL DELIVERY SYSTEM, INJECTOR.
• Patient Age: 65 YR
• Patient Sex: Male