MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	SN6AT5
Medical Device Problem Codes	Malposition of Device (2616); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/17/2022
Type of Reportable Event	Malfunction
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.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that following an intraocular lens (iol) implant procedure, incorrect axis marking of the iol was detected postoperatively.The axis marking is displaced by approx.30 degrees to the haptic legs.Cylinder effect not at desired position.Additional information received and stated that the per the surgeons opinion product defect/batch defect was the cause of the event.Provisional diagnosis mentioned as suspicion of axis rotation.The patent issue was resolved or rather the axis marking was correct, not at the height of the haptics.The patient was not hospitalized.
Event or Problem Description
Additional information received and stated that the iol still implanted and was not rotated.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was not returned for analysis.Only photo was returned.Photo provided shows a magnified image of an implanted iol.The axis marks appear to be in the incorrect location on the optic.One image was submitted and reviewed.The image is of a dilated pupil showing the iol with toric markers highlighted relative to the haptic junctions.The initial report provided that, ¿the axis marking is displaced by approx.30 degrees to the haptic lugs.¿ misalignment of the toric iol axis results in reduction of the cylinder power along the desired meridian.The new residual cylinder may be estimated by the formula r = |2c sin t|, where c is the cylinder power of the toric lens and t is the degree of misalignment.One degree of misalignment results in a loss of approximately 3% of the effective cylinder power, where a misalignment of 30° would roughly negate the intended toric effect.The actual clinical outcome can vary based on lens calculation measurement accuracy, final rotational position of the iol and other clinical factors.In standard procedures where toric misalignment has occurred, online calculators are available for surgeon use for making optimal toric lens rotational adjustment based on residual refractive error.The product did not meet specifications.Based on our observations of the attached photo, the axis marking is displaced by approx.30 degrees to the haptic lugs.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Fda product problems code has been corrected from 2616 to 2911.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 LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 13841526
• Report Number: 9612169-2022-00120
• Device Sequence Number: 17290686
• Product Code: MJP
• UDI-Device Identifier: 00380652250849
• UDI-Public: 00380652250849
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/13/2022

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: 05/31/2024
• Device Model Number: SN6AT5
• Device Catalogue Number: SN6AT5.125
• Device Lot Number: 21246493
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/22/2022
• Supplement Date Received by Manufacturer: 03/30/2022; 05/16/2022; 06/15/2022
• Initial Report FDA Received Date: 03/21/2022
• Supplement Report FDA Received Date: 04/22/2022; 06/13/2022; 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH III CARTRIDGE D.; PROVISC.
• Patient Sex: Female