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

Model Number	SN60WF
Medical Device Problem Codes	Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	11/06/2022
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 healthcare professional reported during an intraocular lens (iol) implant procedure, a complication happened upon delivery of the lens.The lens was removed during initial procedure and replaced with another lens.Additional information has been received and stated that upon delivery of lens posterior capsule ruptured and lens damaged.The lens was explanted and replaced with another lens during same procedure.
Additional Manufacturer Narrative
Correction information was provided in d.9., e.1., h.3., h.6.And h.11.Correction: on initial mdr the product code of a0406 was an error.It should have been a24 on the original mdr additional information was provided in d.9., e.1., h.3., h.6.And h.11.The lens was returned for evaluation.Solution is dried on the lens.One haptic is pointing down into a drain hole in the lens case.The optic is pressed against and between three posts in the lens case.The optic edge is split and torn where it is pressed against the posts.Product history records were reviewed and the documentation indicated the product met release criteria.Qualified associated products were indicated.The product investigation could not identify a root cause.A malfunction has not been indicated against the lens.The event in occurred 6 november 2022.Staff found the box on a shelf.Due diligence has been performed in an attempt to obtain further information on this event.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported during an intraocular lens (iol) implant procedure, a complication happened upon delivery of the lens.The lens was removed during initial procedure and replaced with another lens.Additional information has been received and stated that upon delivery of lens posterior capsule raptured.The lens was explanted and replaced with another lens during same procedure.

• 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: 19132118
• Report Number: 1119421-2024-00740
• Device Sequence Number: 14616861
• Product Code: HQL
• UDI-Device Identifier: 00380655093214
• UDI-Public: 00380655093214
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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 Model Number: SN60WF
• Device Catalogue Number: SN60WF.210
• Device Lot Number: 15436489
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2024
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2022
• 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 OPHTHALMIC VISCOSURGICAL DEVICE; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Outcome Attributed to Adverse Event: Other
• Patient Age: 76 YR
• Patient Sex: Female