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

Model Number	SN6AT3
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 consumer reported that following a cataract extraction with intraocular lens (iol) implant procedure, a line going through the implanted iol.Additional information was received stating the patient was out of town and fell off her bike and hit her head.The patient states that she fractured her cheek, broke one arm, and sprained the other.The cheek fracture was on the opposite side of her iol.She saw a physician who saw there was a crack in her lens.She later followed up with her regular physician, who stated that the line was probably there the whole time.She does not know if it was ever noted in her records prior to the accident.She also does not know if she even saw the line in her vision prior to her accident.
Additional Manufacturer Narrative
Additional information was provided in b.5.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received and stated that, the patient is still dealing with multiple issues.The patient met with surgeon and they feel at this time there is nothing they can do to help correct issues until other things are ruled out.
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.Product history records were reviewed and documentation indicated the product met release criteria.There are no other complaints in this lot.The product investigation could not identify a root cause for the reported complaint.The product was not returned.Information was provided that the patient fell off of their bike.The patient indicated that they suffered a fractured cheekbone, a broken arm and a concussion.Patient was unsure if they saw the line in their vision before the accident.The patient met with the surgeon and they feel at this time there is nothing they can do to help correct issues until other things are ruled out.Patient still having multiple issues related to the concussion.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: 15119292
• Report Number: 1119421-2022-01644
• Device Sequence Number: 20665052
• Product Code: MJP
• UDI-Device Identifier: 00380652249928
• UDI-Public: 00380652249928
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/17/2022

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 Expiration Date: 06/30/2019
• Device Model Number: SN6AT3
• Device Catalogue Number: SN6AT3.215
• Device Lot Number: 12303801
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2022
• Supplement Date Received by Manufacturer: 08/08/2022; 09/19/2022
• Initial Report FDA Received Date: 07/28/2022
• Supplement Report FDA Received Date: 09/02/2022; 10/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2014
• 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
• Patient Sex: Female