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

Model Number	CNWTT0
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Corneal Edema (1791); Blurred Vision (2137); Visual Impairment (2138); Eye Pain (4467); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that about a week after intraocular lens (iol) implantation, patient's refraction turned near-sighted with value more than -1d.Although it was not noticed, the physician suspected that there were cracks in the haptics which caused the iol to become unstable.However, the physician was unclear whether this occurred before the surgery or during implantation.During the follow-up checkup one day after the surgery, the patient told that there was dull pain sometimes and took painkillers twice a day.The lens was removed and replaced with another company lens in a secondary procedure.It was difficult to replace the iol during surgery and as a result, corneal epithelial detachment occurred which resulted in poor visual acuity and unstable reflex.According to surgeon, the visual acuity- would get better if the corneal condition calms down.Additional information was received.In the doctor's opinion, it was considered that the events (pain, swelling, blurred vision, descemet's folds) were not caused by the replacement iol, those were caused by the invasiveness of iol replacement surgery.In addition, all events have been resolved.
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 broken haptics were observed.Intraocular lens (iol) received in four pieces in a bag.Solution is dried on both surfaces of the optic and one haptic.One haptic is broken/torn and not returned, the other haptic is broken/torn and is returned in two pieces.The optic is torn/split-cut dividing the iol in two and scratched/marked-rejectable with an additional large cut/split almost dividing that piece in two.The reporter stated the use of a non-company viscoelastic, which is not qualified for use with the associated iol model.The reporter stated: "the customer suspects that there were cracks in the haptics, etc., which caused the iol to become unstable.It is unclear whether this occurred before the surgery or during implantation." 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 instructions for use (ifu), as the surgeon states the use of non-qualified combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.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 TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 17886006
• Report Number: 9612169-2023-00703
• Device Sequence Number: 15310834
• Product Code: MFK
• UDI-Device Identifier: 00380652408059
• UDI-Public: 00380652408059
• 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: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2023

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: 05/19/2026
• Device Model Number: CNWTT0
• Device Catalogue Number: CNWTT0.165
• Device Lot Number: 25420012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2023
• Supplement Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 12/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2022
• 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 DELIVERY SYSTEM, INJECTOR; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; OPELEAD
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Female