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

Model Number	SA60WF
Medical Device Problem Code	Material Opacification (1426)
Health Effect - Clinical Code	Visual Impairment (2138)
Date of Event	11/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported that "yesterday, while i was in surgery with doctor, he had a patient scheduled for an iol exchange from an company monofocal iol to have exchanged for a panoptix toric lens.The patient originally had a lens implanted in 2018 by another surgeon not in the area.Patient had a very myopic outcome from the surgery in 2018, & doctor also noted opacity on the iol when viewing though the slit lamp." also, "during the surgery yesterday, doctor was unable to safely remove the iol due to bag integrity.He noted the iol was really cocooned in the bag.He ended surgery without removing iol & told the patient they would re-group for a future plan to come back to surgery on another day to do add a piggyback iol & correct residual astigmatism.Dr noted the opacity wasn¿t as bad in surgery as it appeared through the slit lamp.Additional information has been requested and received the patient information.
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
Additional information has been requested and received stating that the iol was explanted and exchanged with a piggyback lens.
Additional Manufacturer Narrative
Additional information has been provided in b.5., d.6.B., h.3., h.6., and h.10.The product was not returned.Two photos were provided.Both showed the same image with different lighting.Both were photos of implanted single-piece iol.Unable to recognize the reported opacity in either of the two photos.Product history records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause for the reported complaint.The lens remains implanted.Review of the provided photos could not determine the area of interest.Information was provided that the original lens was implanted in 2018.Due to difficulty trying to remove the lens, a piggyback lens was placed for the myopic outcome.The surgeon indicated that the noted the opacity wasn¿t as bad in surgery as it appeared through the slit lamp.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).

• 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: 18396754
• Report Number: 1119421-2023-02219
• Device Sequence Number: 4072594
• Product Code: HQL
• UDI-Device Identifier: 00380652332675
• UDI-Public: 00380652332675
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2024

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: 03/31/2023
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.205
• Device Lot Number: 12607830
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2023
• Supplement Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female