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

Model Number	SN60WF
Medical Device Problem Codes	Difficult to Advance (2920); Scratched Material (3020)
Health Effect - Clinical Code	Corneal Edema (1791)
Date of Event	05/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported that, during intraocular lens implant procedure, the iol noted to be scratched after insertion.Additional information was received that, as per surgeon¿s opinion the iol may have not seated when pushing forward/loading.The patient had corneal edema.The iol was exchanged in a secondary procedure.Patient was not hospitalized due to the event.Patient's issues got resolved.Visual prognosis was good.
Additional Manufacturer Narrative
Corrected information provided in b.5.And e.4.Correction: on initial mdr, e.4 was submitted as unknown.This should have been "no" the manufacturer internal reference number is: (b)(4).
Event or Problem Description
The lens was removed and replaced with a back up during the initial procedure.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and documentation indicated the product met release criteria.Qualified associated products were indicated.The product investigation could not identify a root cause for the reported complaint.The product was not returned.Information was provided that the surgeon felt the iol may have not seated when pushing forward/loading.The instructions for use (ifu) instructs: the lens should be inserted until the optic is a little more than half-way inside the cartridge.Use the holding forceps to gently push down on the lens, verifying that the lens is on the bottom surface of the cartridge.Failure to follow this step may cause the lens to advance incorrectly causing delivery issues and/or damage.The manufacturer internal reference number is: (b)(4).

• 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: 14831772
• Report Number: 1119421-2022-01390
• Device Sequence Number: 14045165
• Product Code: HQL
• UDI-Device Identifier: 00380655093276
• UDI-Public: 00380655093276
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2022

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: 04/12/2026
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.240
• Device Lot Number: 15186154
• 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: 06/02/2022
• Supplement Date Received by Manufacturer: 07/07/2022; 08/24/2022
• Initial Report FDA Received Date: 06/27/2022
• Supplement Report FDA Received Date: 08/02/2022; 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2021
• 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: MONARCH II IOL CARTRIDGE B; MONARCH II IOL INJECTOR; PROVISC
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown