MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	SN6AT3
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Malfunction
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 other healthcare professional reported that during the intraocular lens (iol) implant procedure the lens was pinched in the cartridge and was damaged.The surgery was completed with the replacement lens during initial procedure.There was no patient ham.Additional information has been requested.
Additional Manufacturer Narrative
The lens was returned adhered in solution outside the well area of a disassembled lens case.Viscoelasetic was dried on the lens.One haptic was broken in the haptic/optic junction and into the optic material.The broken haptic was not returned.The optic edge has additional broken area near the broken haptic.The broken optic portion was not returned.The optic anterior has a cracked area near the broken optic and broken haptic damage.The posterior of the optic has more than nine separate cracked areas (small to large) near the broken haptic and broken optic damage.The cracked damage appeared to travel toward the optic center.Product history records were reviewed and documentation indicated the product met release criteria.Information was provided that a non-qualified cartridge and non-qualified viscoelastic were used.The handpiece information was not provided.The root cause for the reported complaint was most likely related to a failure to follow the (instructions for use) ifu.The company 26.5 diopter lens is not qualified for use in the indicated company d cartridge.The qualified diopter range for the company d cartridge is 6.0-25.0.Also, the viscoelastic indicated is not a qualified viscoelastic for this lens when used with qualified associated products.The ifu instructs: company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that an company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been received that the damage of lens happened during preparation stage.There was no patient contact.
Additional Manufacturer Narrative
Based on information received following submission of the initial report, this event does not meet criteria for reporting as a reportable device malfunction.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 18416755
• Report Number: 1119421-2023-02233
• Device Sequence Number: 20795264
• Product Code: MJP
• UDI-Device Identifier: 00380652250023
• UDI-Public: 00380652250023
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/20/2024

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: SN6AT3
• Device Catalogue Number: SN6AT3.265
• Device Lot Number: 15588972
• 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: 12/04/2023
• Supplement Date Received by Manufacturer: 02/13/2024; 04/23/2024
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 03/12/2024; 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2023
• 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: MONARCH III CARTRIDGE D.; PROVISC.
• Patient Age: 66 YR
• Patient Sex: Female