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

Model Number	SN60WF
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Capsular Bag Tear (2639)
Date of Event	02/01/2024
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 physician reported that during intraocular lens implantation, the haptic broke causing the chamber rupture.Vitrectomy procedure was performed and the patient was left aphakic.Additional information was requested, but no further information is available.
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 and handpiece.The viscoelastic information was not provided.It is unknown if a qualified product was used.The product investigation could not identify a root cause for the reported complaint.The product has not been received to evaluate.The viscoelastic information was not provided.It is unknown if a qualified product was used.The ifu instructs: company foldable iols are qualified for use with a company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that a company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.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
Additional information was provided in d.9., h.3., h.6.And h.11.The lens was returned positioned incorrectly in the lens case.Blood and solution was dried on the lens.One haptic was broken in the gusset area (returned).The optic was cut from edge past center, typical of insertion and removal.A used qualified cartridge was returned.An inadequate amount ovd was observed in the cartridge.A broken haptic was observed still inside the cartridge up against the roof, between the loading area and the nozzle entry area.The cartridge does show evidence that it has been placed into a handpiece.No tip damage observed.Product history records were reviewed and the documentation indicated the product met release criteria.The account indicated the use of a qualified associated cartridge and handpiece.The viscoelastic information was not provided.It is unknown if a qualified product was used.The reported broken haptic damage was observed.The root cause appears to be related to a failure to follow the ifu.An inadequate amount of viscoelastic was observed in the returned used cartridge.The ifu instructs to completely fill the cartridge with ovd (diagram provided) immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.In addition, the viscoelastic information was not provided.It is unknown if a qualified product was used.The ifu instructs: company foldable iols are qualified for use with a company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that a company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.The root cause for the reported ¿capsule rupture, and vitrectomy" complaint could not be determined.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 if 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: 18814975
• Report Number: 1119421-2024-00366
• Device Sequence Number: 8531351
• Product Code: HQL
• UDI-Device Identifier: 00380655093252
• UDI-Public: 00380655093252
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/11/2024

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 Expiration Date: 03/03/2025
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.230
• Device Lot Number: 15053803
• 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: 02/02/2024
• Supplement Date Received by Manufacturer: 03/21/2024; 05/16/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 04/15/2024; 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2020
• 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 III CARTRIDGE D; MONARCH III INJECTOR
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Female