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

Model Number	SA60AT
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was not returned.Photos were provided.One photo displayed the end of the carton with product information.Two identical photos displayed the same non-company viscoelastic.Another photo displayed the back of a company cartridge pouch with product information and the back of the lens carton.The lens was not shown in any of the provided photos.Product history records were reviewed and the documentation indicated the product met release criteria.A qualified lens and cartridge combination was used.An unspecified "company" handpiece was used.The viscoelastic was clarified and identified by the provided photos.A noncompany nonqualified viscoelastic was used.The sample was not returned.Photos were provided only of the lens carton, cartridge pouch, and noncompany viscoelastic pouches.The root cause for the reported complaint was most likely related to a failure to follow the ifu.A non-qualified viscoelastic was used.The ifu instructs: company foldable iols are qualified for use with company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that 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.Information was provided that the company lens 21.0 diopter was removed and exchanged for a same lens of the same diopter.Please be aware that there is currently a ban on the export of medical devices from the russian federation.The file will be reopened if the sample becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health care professional reported during intraocular lens (iol) implant procedure, the torn of iol was found.Additional information has been received stating the haptic detachment had occurred while the lens was passing through the cartridge.Surgeon had to cut it and explant the lens from the eye and implanted the same iol of same diopter in the eye completed surgery on same day.Patient's current condition was satisfactory with no patient harm.

• Brand Name: ACRYSOF SINGLEPIECE 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: 20554587
• Report Number: 1119421-2024-02112
• Device Sequence Number: 8996467
• Product Code: HQL
• UDI-Device Identifier: 00380652555821
• UDI-Public: (01)00380652555821(17)281007(11)231010(10)15731396
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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
• Report Date (Section B): 10/29/2024

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: SA60AT
• Device Catalogue Number: SA60AT.210
• Device Lot Number: 15731396
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 10/29/2024
• Date Device Manufactured: 10/10/2023
• 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 IOL CARTRIDGE C.; MONARCH IOL INJECTOR,; NON-COMPANY OVD.
• Patient Sex: Unknown