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

Model Number	CNWTT3
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A health care professional reported that during surgery, on (b)(6) 2024, during the lens implant, a crack was discovered on the edge of the lens and an exchange was performed on the same day.Additional information has been requested.
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
The product was returned for analysis and the reported complaint was observed.Iol returned cut in two inside the lens case.Solution is dried on the iol.Both haptics are intact.The optic is cracked/fractured near the optic edge.We are unable to determine the root cause for the reported complaint, "crack was discovered on the edge of the lens".The returned iol has solution dried on the iol.The product was subject to handling as the reported complaint was highlighted post implantation and the observed damage is consistent with lens having been explanted.All iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed damage would not meet our current release criteria.Based on these investigation findings, we are unable to verify if the iol contributed to the event.Based on the results from the product history record, the products met release criteria.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: 19750810
• Report Number: 9612169-2024-00700
• Device Sequence Number: 20477769
• Product Code: MJP
• UDI-Device Identifier: 00380652468428
• UDI-Public: (01)00380652468428(17)241203(11)210712(10)25233066(21)25233066129
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2024

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 Expiration Date: 12/03/2024
• Device Model Number: CNWTT3
• Device Catalogue Number: CNWTT3.145
• Device Lot Number: 25233066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2021
• 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
• Patient Sex: Unknown