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

Model Number	CNWTT4
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was returned for analysis.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.Results from the product history record review indicated the product met release criteria.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported that during implantation of an intraocular lens (iol) the mark which seemed to be either a white glue-like foreign material or a damage was found on the haptic after implanting.It was not able to be removed although removal through irrigation and aspiration was attempted.The surgery was completed by explanting the iol and implanting the backup lens.Additional information was requested.
Additional Manufacturer Narrative
Additional photos provided showing 3 segments of the iol.Two segments of the iol are in the lens case.Both segments have a haptic attached to the optic.One haptic appears to have a dry residue on the haptic tip - a potentially dried solution.The other haptic tip appears to be chipped/nicked, however due to the angle the photo is taken, a definitive determination of the damage cannot be made.The third segment of the optic is visible in a zip-lock bag.A definitive determination of damage cannot be made without the evaluation of the physical product as only one intact haptic is returned.A final root cause cannot be determined based on available information.Investigation results remains unchanged.The product was returned for analysis and the reported complaint was not observed.Video was provided showing haptic tip damage.A fragment of the iol(intraocular lens) returned in zip locked pouch.Another fragment of the iol returned in company iol case.Solution is dried on both surfaces of the optic and one haptic.One haptic is broken/torn and is not returned, the other haptic is intact.The optic is cut into pieces, two fragments are returned scratched/marked-rejectable.The iol was cleaned, no issues were observed.Video shows iol implantation.Footage on the lens preparation for the implantation is not provided.The lens appears to be in an acceptable position for the implantation.Post implantation the trailing haptic tip appears to be damaged/chipped/nicked.We are unable to determine the root cause for the reported complaint "white glue-like foreign material or damage on haptic".Segments of the iol optic and one haptic returned.The returned haptic is intact.The other haptic is not returned.Video was provided showing trailing haptic tip damage.A definitive determination of damage cannot be made without the evaluation of the physical product as only one intact haptic is returned.A final root cause cannot be determined based on available information.In addition to this, all iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed lens 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: 14572800
• Report Number: 9612169-2022-00246
• Device Sequence Number: 20377782
• Product Code: MJP
• UDI-Device Identifier: 00380652468831
• UDI-Public: 00380652468831
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2022

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: 02/04/2025
• Device Model Number: CNWTT4
• Device Catalogue Number: CNWTT4.085
• Device Lot Number: 25271356
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2022
• Supplement Date Received by Manufacturer: 09/15/2022
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2021
• 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 IOL INJECTOR.; MONARCH III IOL CARTRIDGE D.; OPEGAN-HI.
• Patient Sex: Unknown