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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	11/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A nurse reported following an intraocular lens implant procedure, the patient could not see well reading or distance.Near vision target not near enough for her needs.The lens was later exchanged in a secondary procedure.Additional information has been requested and received which states that this lens issue was discovered (b)(6) 2021.Patient was a contact lens wearer.She was a +2.00 hyperope.She used this left eye for near for monovision.We calculated for her a residual of -1.88 with the barrett formula.She ended up one month post op on (b)(6) 2021 with a refraction of plano-0.75x085 = 20/30.Her surgery was routine with no complications.The lens loaded easily, opened easily in the eye and centered well.Post operatively she complained of decreased near vision.Her original k readings average was 47.46 and post op three months was 47.27 so her lack of near vision was not due to a dramatic change in k readings.The issue there for was simply between the desired and achieved refractive error.
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
Additional information has been received and it was reported that a 27.0d lens was exchanged for a 29.0d lens due to blurred vision near and distance.This does not meet criteria for reporting based on applicable medical device regulations.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.
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).

• 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: 13967111
• Report Number: 1119421-2022-00649
• Device Sequence Number: 14494069
• Product Code: HQL
• UDI-Device Identifier: 00380652335904
• UDI-Public: 00380652335904
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2022

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: 06/30/2022
• Device Model Number: SA6AT3
• Device Lot Number: 12552502
• 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: 03/09/2022
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2017
• 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: ACRYSOF ASPHERIC UV ABSORBING SINGLEPIECE IOL.; BSS STERILE IRRIGATING SOLUTION.; DUOVISC VISCOELASTIC SYSTEM.; XYLOCAINE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown