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

Model Number	SY60WF
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lens was returned in a specimen cup with a sponge inside the lens carton.The lens was intact.A small amount of solution and what appeared to be gauze fibers were dried on the lens.The lens was cleaned with klrp.The returned lens does not have toric axis marks.No damage or anomalies were observed that could have been interpreted as axis marks.The power and resolution of the returned lens were verified to meet specification for a non-toric company, 16.0 diopter lens.Product history records were reviewed, and documentation indicated the product met release criteria.No problem was found with the returned company lens.The returned lens did not have toric axis marks.No damage or anomalies were observed that could have been interpreted as axis marks.The power and resolution of the returned lens were verified to meet specification for a non-toric company, 16.0 diopter lens.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported that during intraocular lens (iol) implantation procedure, they implanted an iol that had toric marking dots but was not a toric lens.The lens was removed in an initial procedure.Additional information was received.In the surgeon's opinion, the iol was defective.The surgeon removed the iol once it was implanted and replaced with another iol in same procedure.There was no patient harm, patient's issues were resolved after replacement.

• 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: 18693931
• Report Number: 1119421-2024-00265
• Device Sequence Number: 18225815
• Product Code: HQL
• UDI-Device Identifier: 00380652251402
• UDI-Public: 00380652251402
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/13/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SY60WF
• Device Catalogue Number: SY60WF.160
• Device Lot Number: 15659470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2023
• 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; LENS LOADING FORCEPS; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Age: 64 YR
• Patient Sex: Female