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

Model Number	SN6AT7
Medical Device Problem Codes	Break (1069); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported during the intraocular lens implantation the lens was decentered and after careful observation there was a break at the optic haptic junction.Due to that the lens was extracted and a monofocal lens was implanted.There was no harm or impact to the patient.
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
Additional information provided in d.9., h.3., h.6., and h.10.The carton with the label set and id card were returned.Information was provided in the file that indicated the use of a qualified cartridge and handpiece.A non-qualified viscoelastic was indicated.The root cause for the reported complaint may be related to a failure to follow the instructions for use (ifu).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).

• 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: 17069250
• Report Number: 1119421-2023-01028
• Device Sequence Number: 14975996
• Product Code: MJP
• UDI-Device Identifier: 00380652275941
• UDI-Public: 00380652275941
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2023

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: SN6AT7
• Device Catalogue Number: SN6AT7.210
• Device Lot Number: 15390653
• 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: 05/08/2023
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 08/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2022
• 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: ACTIVE SENTRY HANDPIECE; AUROVISC; J&J MONOFOCAL LENS; MONARCH III CARTRIDGE D; MONARCH III INJECTOR
• Patient Sex: Unknown