MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL; INTRAOCULAR LENS

Model Number	SY60WF
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A registered nurse reported about a lens being explanted in a secondary procedure due to lens when checked post operatively found to be decentered.The lens was replaced with non company lens.
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is:( b)(4).
Additional Manufacturer Narrative
The lens was returned inside a small brown envelope in folded white gauze material.Solution was dried on the lens.The optic was broken into two portions.The optic edge has an area that was broken.The lens material from the broken optic edge was not returned.One haptic was bent in the gusset and distal area.Product history records were reviewed and the documentation indicated the product met release criteria.The account indicated the use of qualified associated products.Based on information provided on the completed customer questionnaire, the root cause was explained to be unrelated to the lens.The questionnaire answered the question of "if no, in the surgeon's opinion what caused the event?" with their answer: mechanical defect.The cause of the decentered iol is not known, and it is unclear what is meant by "mechanical defect.The explanted lens was broken into two portions with additional lens damage.This lens damage may have been interpreted as the "mechanical defect", damaged during use.Qualified associated products were used.It is unknown how long the lens was allowed to remain in a folded condition inside the cartridge.The ifu instructs: follow the section regarding directions for use for information on the maximum allowed time for the iol to stay in the folded condition.Failure to adhere to manufacturer¿s recommendations may result in iol damage.Ifu note: during lens loading and insertion, do not allow the iol to remain in a folded condition within the selected iol delivery system for more than 3 minutes prior to completing insertion into the capsular bag.Information was provided in the file that the company lens 17.0 diopter lens was removed and replaced with a non- company monofocal lens, +15.0 diopter.This information may suggest that the two diopters less of the replacement non-company monofocal lens may have been an improved selection for this patient's vision needs.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL
• Common Device Name: INTRAOCULAR LENS
• 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: 17390313
• Report Number: 1119421-2023-01330
• Device Sequence Number: 6780052
• Product Code: HQL
• UDI-Device Identifier: 00380652251426
• UDI-Public: 00380652251426
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2023

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: 03/12/2025
• Device Model Number: SY60WF
• Device Catalogue Number: SY60WF.170
• Device Lot Number: 15292084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/03/2023
• Supplement Date Received by Manufacturer: 11/12/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female