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

Model Number	SN60WF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	12/21/2023
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 non-healthcare professional reported that during surgery, they noticed posterior capsule torn upon delivery of lens.Back up lens was used as replacement.Additional information has been requested and received stating the procedure was completed on the same day.
Additional Manufacturer Narrative
The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.The account indicated the use of a qualified associated cartridge, handpiece and viscoelastic.The product investigation could not identify a root cause for the reported posterior capsule torn upon delivery.The product has not been received to evaluate.The cause of the posterior rupture was not provided.Follow up attempts were made.No further information has been provided at this time.File will be reopened when new information or the product is received.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The lens was returned positioned incorrectly in the lens case.Solution is dried on the lens.One haptic was bent in the gusset and distal area.The optic was torn from edge towards center.Product history records were reviewed and the documentation indicated the product met release criteria.The account indicated the use of a qualified associated cartridge, handpiece and viscoelastic.The product investigation could not identify a root cause for the reported posterior capsule torn upon delivery.The cause of the posterior rupture was not provided.A malfunction has not been indicated or information provided that the lens was the cause of the event.Due diligence has been performed in an attempt to obtain further information on this event.No further information has been provided at this time.File will be reopened when new information is received.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: 19019251
• Report Number: 1119421-2024-00599
• Device Sequence Number: 7939274
• Product Code: HQL
• UDI-Device Identifier: 00380655093313
• UDI-Public: 00380655093313
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/15/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.260
• Device Lot Number: 15600897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 04/19/2024; 06/17/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 05/17/2024; 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2023
• 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: ANTERIOR CHAMBER PMMA SINGLEPIECE IOL; DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Female