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

Model Number	SA6AT3
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported that during an intraocular lens (iol) implant procedure, defect on the lens was noticed after implantation.Subsequently the lens was removed during initial procedure and completed with another lens and surgery completed without complications.
Additional Manufacturer Narrative
Complaint history and product history records were reviewed and the documentation indicated the product met release criteria.The root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was not returned.A photo was available that displayed the lens viewed on the screen of a monitor.The lens was shown inside the eye.A tool used for aspiration was shown in the photo.The optic anterior edge has a v shaped shadowy area which appeared to be a nicked area of damage.The optic has a long, linear shadow.This shadow may be optic damage.A final confirmation cannot be made without a physical evaluation.Product history records were reviewed and the documentation indicated the product met release criteria.The file indicates he use of a qualified cartridge and handpiece.Two viscoelastics were indicated, only one is qualified for this lens with the qualified cartridge combinations.Based on our observation of the attached photos, there are markings on the optic that are similar to lens damage.It is difficult to make a final determination without evaluation of the physical sample.The root cause cannot be determined based on available information.Company foldable iols are qualified for use with a company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The instructions for use (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 ifu instructs: using holding forceps, grasp the lens by the optic edge and gently place the lens anterior side up into the back of the ovd-filled cartridge.The lens should be inserted until the optic is a little more than half-way inside the cartridge.Use the holding forceps to gently push down on the lens, verifying that the lens is on the bottom surface of the cartridge.Using holding forceps, take the trailing haptic, and gently fold the haptic onto the anterior side of the optic.Slowly grip or push the optic edge to position the lens as far into the cartridge as the forceps will permit, while ensuring the lens remains on the bottom surface of the cartridge and the trailing haptic remains on the optic.Failure to follow these steps may cause the lens to advance incorrectly causing delivery issues and/or damage.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The lens was returned positioned incorrectly in the lens case.Solution was dried on the lens.The optic was cut in half, typical of insertion and removal.One cut optic portion had a deep scrape mark between the central optic zone and the optic edge.The photo provided appears to be of the returned sample.Product history records were reviewed and the documentation indicated the product met release criteria.The file indicated the use of a qualified cartridge and handpiece.Two viscoelastics were indicated, only one is qualified for this lens with the qualified cartridge combinations.The root cause could not be determined for the reported ¿defect¿ complaint.The specific lens issue was not specified.Damage to the lens was observed.While we are unable to determine the root cause of the lens damage, our observation reasonably suggests that it is not manufacturing related.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely related to customer handling.The file indicated the use of a qualified cartridge and handpiece.Two viscoelastics were indicated, only one is qualified for this lens with the qualified cartridge combinations.Company foldable intraocular lenses (iols) are qualified for use with a company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The instructions for use (ifu) instructs that a 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 ifu instructs: using holding forceps, grasp the lens by the optic edge and gently place the lens anterior side up into the back of the ovd-filled cartridge.The lens should be inserted until the optic is a little more than half-way inside the cartridge.Use the holding forceps to gently push down on the lens, verifying that the lens is on the bottom surface of the cartridge.Using holding forceps, take the trailing haptic, and gently fold the haptic onto the anterior side of the optic.Slowly grip or push the optic edge to position the lens as far into the cartridge as the forceps will permit, while ensuring the lens remains on the bottom surface of the cartridge and the trailing haptic remains on the optic.Failure to follow these steps may cause the lens to advance incorrectly causing delivery issues and/or damage.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF TORIC ASPHERIC UV ABSORBING 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: 19891136
• Report Number: 1119421-2024-01500
• Device Sequence Number: 7796301
• Product Code: HQL
• UDI-Device Identifier: 00380652335843
• UDI-Public: (01)00380652335843(17)270511(11)220513(10)15396257
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2025

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: SA6AT3
• Device Lot Number: 15396257
• 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: 07/05/2024
• Supplement Date Received by Manufacturer: 07/31/2024; 12/18/2024
• Initial Report FDA Received Date: 08/02/2024
• Supplement Report FDA Received Date: 08/28/2024; 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2022
• 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: DUOVISC VISCOELASTIC SYSTEM; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR; REPLACEMENT LENS: UNSPECIFIED IOL
• Patient Sex: Unknown