MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF ASPHERIC UV ABSORBING SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SA60WF
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	Visual Impairment (2138)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lens was returned positioned incorrectly in the replacement lens case.The lens was cracked in one optic/haptic junction.The lens was cleaned with klrp (klotho-related protein).The optical resolution was acceptable; lens met specification for focal length equaling a 18.5 diopter lens.Product history records were reviewed and documentation indicated the product met release criteria.No problem was found.The returned lens optical resolution was acceptable.The lens met specification for focal length equaling a 18.5 diopter lens.Each lens is subjected to a 100% assessment of the power and optical resolution during the manufacturing process in order to determine acceptability per the lens model and diopter.The unexpected myopia was reported to be 2.0 diopters.Information was provided that the company 18.5 diopter lens was replaced with a company 20.5 diopter lens.An iol exchange for a difference equal to or greater than two diopters, indicates the event is most likely related to a calculation error.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that during initial implant procedure, patient had almost 2 diopters of unexpected myopia.Lens was explanted and exchanged with another monofocal lens.Additional information has been requested.

• Brand Name: ACRYSOF ASPHERIC UV ABSORBING 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: 17017157
• Report Number: 1119421-2023-00989
• Device Sequence Number: 15245890
• Product Code: HQL
• UDI-Device Identifier: 00380652332637
• UDI-Public: 00380652332637
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/29/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2026
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.185
• Device Lot Number: 15262301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 05/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2021
• 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: CLAREON ASPHERIC UV ABSORBING IOL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown