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

Model Number	SN6AT4
Medical Device Problem Code	Application Program Problem: Power Calculation Error (1473)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/07/2022
Type of Reportable Event	Serious Injury
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 following an intraocular lens implant procedure, the calculation of the lens was found out to be calculated in an erroneous way.The surgeon performed a secondary surgery to rotate the lens, but the haptic was stuck very strong and the surgeon was not able to pull out the lens.It was discussed with the patient but the patient decided that she would preferred an external aid to correct the residual astigmatism (the one she had been using before surgery: toric contact lenses) and since it was resolved.The patient was satisfied with a toric contact lens after the surgery of the 1st eye.Additional information has been requested.
Additional Manufacturer Narrative
The product was not returned for analysis.The root cause for the reported complaint appears to be a coincidental event, that was not related to product, but to calculation issue.As it is stated in the file, that surgeon made the calculation of the lens in an erroneous way.A malfunction has not been indicated or information provided, that the lens was the cause of the event.Based on this information, the product did not cause/contribute to the event.Based on the results from the product history record, the products met release criteria.There have been no other complaints for this lot.Investigation has been completed, based on current information.No further action is warranted at this time.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: 14285430
• Report Number: 9612169-2022-00202
• Device Sequence Number: 5198864
• Product Code: MJP
• UDI-Device Identifier: 00380652250467
• UDI-Public: 00380652250467
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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): 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: SN6AT4
• Device Catalogue Number: SN6AT4.220
• Device Lot Number: 21259171
• 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: 04/07/2022
• Supplement Date Received by Manufacturer: 05/29/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female