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

Model Number	SN60WF
Medical Device Problem Codes	Defective Component (2292); Failure to Eject (4010)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A non-healthcare professional reported that during the cataract surgery with intraocular lens (iol) implant procedure, the haptics did not come out of the cartridge.The lens came out without a haptic later on.Additional information has been requested.
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The lens was returned for evaluation.Solution is dried on the lens.One haptic is broken in the gusset area and returned loose in the lens case.The lens is pressed against a post in the lens case.Light scratches are observed on the optic surface.The returned lens matches the provided photo(s).Associated products were not provided.It is unknown if qualified products were used.Broken haptic damage was observed.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met company release criteria.Based on our observation, it can be reasonably concluded that the damage is not manufacturing related.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely related to customer handling.Company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The instruction for use (ifu) instructs that an 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 lens was returned in the lens case.We are unable to verify the lens was stuck in the delivery system.Follow up attempts were made.At this point, no further information available at this time.Two photos were provided of the lens in the lens case.Both pictures show one haptic laying in a way to appear broken in the gusset area.Solution is present on the lens.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: 17315407
• Report Number: 1119421-2023-01253
• Device Sequence Number: 6226241
• Product Code: HQL
• UDI-Device Identifier: 00380655095683
• UDI-Public: 00380655095683
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.135
• Device Lot Number: 12757803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2023
• Supplement Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2019
• 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
• Patient Sex: Unknown