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

Model Number	SN60WF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	05/26/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported that following an intraocular lens (iol) implant procedure, the patient had residual 3.0d myopia after surgery.The lens was still in patients eye.The doctor was concerned that the information on the product's label might be incorrect.No more further information received and stated that, the iol was replaced during a secondary procedure with 14.0 diopter.
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).
Additional Manufacturer Narrative
Based on information received, following submission of the initial report, this event does not meet criteria for reporting as a serious injury.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received.And stated that, the iol was replaced, during a secondary procedure with 14.0 diopter.It was reported, that a 17.0 lens was exchanged for a 14.0 lens, due to residual 3.0d myopia.After surgery.A lens exchange from one power to a different power is an attempt to adjust or fine tune the refractive outcome.Trying to achieve a desired target, when the initial lens calculations did not achieve the intended outcome.There is no reported defect or fault with the lens.

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Common Device Name: INTRAOCULAR LENS
• 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: 14751872
• Report Number: 1119421-2022-01322
• Device Sequence Number: 14006610
• Product Code: HQL
• UDI-Device Identifier: 00380655093139
• UDI-Public: 00380655093139
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2022

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: 01/07/2025
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.170
• Device Lot Number: 15003311
• 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: 05/26/2022
• Supplement Date Received by Manufacturer: 07/04/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2020
• 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: REPLACED LENS WITH 14.0
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown