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

Model Number SN60WF

Device Problems Defective Component (2292); Failure to Eject (4010)

Patient Problem Insufficient Information (4580)

Event Date 12/05/2022

Event Type  malfunction  

Event Description

A non-healthcare professional reported during an intraocular lens (iol) implant procedure, the haptic on the lens did not fold in properly, when surgeon attempted to insert the lens in the eye it did not advance correctly so lens was not completely inserted.Additional information was requested.

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.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The lens was returned positioned incorrectly in the lens case.Solution was dried on the lens.One haptic was broken in the distal tip area (not returned).The lens was cleaned with klrp for further evaluation.Both haptics were pliable when manipulated.No issues observed.The optic was torn/split/cracked from edge towards center.A fold inspection could not be conducted due to the extensive optic damage.No cartridge was retuned for evaluation.Associated products were not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause for the reported event.The lens was returned in the lens case and not returned stuck in a cartridge as described.The lens was removed from the lens case and cleaned with klrp for further evaluation.Both haptics were pliable when manipulated.No issues observed.Other lens 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, and the review of manufacturing records, 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.Associated products were not provided.It is unknown if qualified products were used.The 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.Company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Type of Device: 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: 16086895
• MDR Text Key: 308366345
• Report Number: 1119421-2023-00024
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380655095652
• UDI-Public: 00380655095652
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.120
• Device Lot Number: 15115527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Male