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

Model Number	CCWTT5
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A non health care professional reported that, during intraocular lens implant procedure, it was noted that the lens was defective.The lens was exchanged during the same procedure.Additional information was received stating during surgery, the surgeon placed the lens inside the patient¿s eye when he noticed that the lens would not unfold.The lens was removed from the patient¿s eye, a replacement lens was used to complete the surgery the same day.No patient harm was reported.
Additional Manufacturer Narrative
A sample device was not returned for analysis.Product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was returned for analysis and damage was observed to the intraocular lens.Intraocular lens received in lens case in zip lock bag.Intraocular lens crushed into lens case base.Solution is dried on both surfaces of the optic and haptics.One haptic is broken/torn and is returned, the other haptic is nicked at the gusset area.The optic is split in two and scratched/marked-rejectable.Unable to perform fold test due to the condition of the returned sample.The complainant indicates the use of non-company as a viscoelastic.Non-company is not qualified for use with company model.While we are unable to determine the origin of the reported complaint, our observations reasonably suggest that it is not manufacturing related.Based on the information provided by the customer, the most likely root cause is failure to follow the company instruction of company qualified intraocular lens delivery system product combinations and alternative viscoelastics.The use of nonqualified combinations may result in delivery issues and/or damage.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 UV ABSORBING 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: 15607927
• Report Number: 9612169-2022-00533
• Device Sequence Number: 2314727
• Product Code: MJP
• UDI-Device Identifier: 00380652458344
• UDI-Public: 00380652458344
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2022

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: 02/27/2026
• Device Model Number: CCWTT5
• Device Catalogue Number: CCWTT5.150
• Device Lot Number: 25357451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2022
• Supplement Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 12/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CLAREON MONARCH IV IOL, INJECTOR.; HEALON.; MONARCH III IOL, CARTRIDGE D.
• Patient Sex: Unknown