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

Model Number	SA60WF
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	11/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.Information was provided that indicated the use of a qualified cartridge, handpiece, and viscoelastic combination.Based on information provided from the surgical site on the response, the root cause is unrelated to the iol.It was stated that the incision needed to be enlarged, and the lens had already been loaded and halfway through injector when removed.Asked for a new lens.The file indicated that the initial lens was destroyed.No product will be returning.Information in the file indicated that a 22.5 diopter lens was used.An explanation was not provided regarding the decision to select a lens with 1.5 diopters less as the replacement lens than the initial lens 24.0 diopter.No further information has been provided.There has been two other complaints in this reported lot number.The manufacturer internal reference number is:(b)(4).
Event or Problem Description
A purchasing person reported that following an intraocular lens (iol) implant procedure, the lens open but not used.Additional information has been requested and provided that defective haptic and the incision needed to be enlarged and the lens had already been loaded and halfway through injector when removed.Asked for a new lens.There was no patient harm and no hospitalization.

• 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: 13522093
• Report Number: 1119421-2022-00265
• Device Sequence Number: 4158223
• Product Code: HQL
• UDI-Device Identifier: 00380652332743
• UDI-Public: 00380652332743
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/14/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/20/2026
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.240
• Device Lot Number: 15236515
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 02/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2021
• 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: DISCOVISC; MONARCH III IOL CARTRIDGE D; MONARCH III IOL, INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown