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	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2022
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 physician reported that, one day following intraocular lens (iol) implant procedure, it was noticed that there were additional toric marks on the iol (another set of marks located about 80 degrees from one of the marks).The lens was left implanted in eye because, the patient was seeing very well.Additional information was requested.
Additional Manufacturer Narrative
The product was not returned, lens remained implanted.A photo was provided of the lens in the eye.One set of three molded axis marks are visible in the upper left quadrant as designed.The second set of marks are not visible due the irrigation and aspiration (i/a) probe in the photo.An area in the lower left quadrant is circled in yellow.What may be shadows are observed.Due to the clarity of the photo, it cannot be determined if this is damage or a surface anomaly which may give the appearance of an axis mark.No determination can be made from the photo.Product history records were reviewed and documentation indicated the product met release criteria.The root cause for the reported "additional toric marks" cannot be determined.No determination can be made without physical evaluation of the complaint sample.Due to the specific molding process and 100% inspection for the axis mark alignment, a lens with additional marks would not pass inspection criteria.Toric axis marks must be within a specified range at the optic/haptic junction.All lenses are 100% inspected for this attribute.Lens resolution and focal length are based on the alignment of the toric axis marks with 100% inspection for this function.Axis marks are created by indentions in the pin.The validated program used to make the axis marks is setup to create only one set.The pin is then inspected to ensure the axis marks are in the correct location and an additional inspection is performed at molding before use.One lens could not be created that would have additional axis marks.All product produced with the pin would be identical.This is the only complaint fro this lot and this is the only complaint of this type.There have been no other complaints reported in the lot number.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: 13521250
• Report Number: 1119421-2022-00258
• Device Sequence Number: 14571136
• Product Code: HQL
• UDI-Device Identifier: 00380652335812
• UDI-Public: 00380652335812
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2022

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: 09/30/2024
• Device Model Number: SA6AT3
• Device Lot Number: 12746324
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2022
• Supplement Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 05/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2019
• 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: Unknown