MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON PANOPTIX TRIFOCAL HYDROPHOBIC INTRAOCULAR LENS; LENS, MULTIFOCAL INTRAOCULAR

Model Number	CNWTT0
Medical Device Problem Code	Optical Decentration (1360)
Health Effect - Clinical Code	Blurred Vision (2137)
Type of Reportable Event	Serious Injury
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).
Event or Problem Description
A facility representative reported that following the intraocular lens (iol) implant procedure, the patient had blurred vision.The lens was exchanged for an unknown advanced technology intraocular lens (atiol) 4 months, 21 days after the initial implant procedure.The clinical reason was lens decentration.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was provided in b.5.And d.10.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received stating that, the iol was implanted in the eye.
Additional Manufacturer Narrative
The lens was returned submerged in balanced salt solution (bss) solution.Lens was removed to air dry prior to evaluation.Blood was dried on the lens.The lens was cleaned with keratometer lens refractive polisher (klrp) to further evaluate.The posterior optic surface was scratched near the edge.The center of the optic on the anterior surface was cracked and scratched.The anterior optic surface has an additional scratch located between the center and the edge.Product history records were reviewed, and the documentation indicated the product met release criteria.Associated product information was not provided it is unknown if qualified products were used.The root cause cannot be determined for the reported complaint of lens decentration, blurry vison.The explanted lens was returned and evaluated.The power and resolution were verified.The returned lens met specification for power and resolution for a company 19.5 diopter lens.Each lens is subjected to a 100 percent assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.Information was provided that the company 19.5 diopter (add power +2.2/+3.2 diopter) was removed and replaced.The replacement lens information was not provided.Due diligence has been performed in an attempt to obtain further information on this event.The reporter has not responded to request for follow-up information.File will be reopened if new information is received.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 RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 20178527
• Report Number: 1119421-2024-01766
• Device Sequence Number: 8196584
• Product Code: MFK
• UDI-Device Identifier: 00380652408110
• UDI-Public: (01)00380652408110(17)260523(11)220525(10)15413269
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/09/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/23/2026
• Device Model Number: CNWTT0
• Device Catalogue Number: CNWTT0.195
• Device Lot Number: 15413269
• 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: 08/12/2024
• Supplement Date Received by Manufacturer: 09/19/2024; 11/12/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 10/16/2024; 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2022
• 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: REPLACEMENT LENS: UNSPECIFIED ATIOL.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown