MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number AU00T0

Device Problem Defective Component (2292)

Patient Problem Capsular Bag Tear (2639)

Event Date 12/12/2022

Event Type  Injury  

Manufacturer Narrative

The product was not returned for analysis.Complaint history and product history records were reviewed and the documentation indicated the product met release criteria.The root cause has not been identified.There have been no other complaints for this lot.The manufacturer internal reference number is: (b)(4).

Event Description

A other healthcare professional reported that leading haptic of the iol came out facing directly inferiorly and toward the posterior capsule.The leading haptic tore the posterior capsule.Additional information requested and received stating scheduled procedure was cataract extraction with iol implantation and procedure completed.There was no medical or surgical intervention required as a result of this event and patient not hospitalized as a result of this event.

Manufacturer Narrative

Additional information provided in h.3., h.6.And h.10.The product was not returned.A video was provided.The device preparation was not shown in this video.The eye comes into view.The device nozzle was shown being inserted into the incision.The leading haptic was in an acceptable question mark shape while inside the device at the fill line.The trailing haptic was in an acceptable position inside the optic fold.The plunger tip was observed engaging the trailing optic edge.The lens was advanced into the eye.While advancing, the leading haptic appeared to hesitate, becoming misfolded in the tip area while the plunger was advanced.As the lens was exiting the device tip, the misfolded leading haptic was facing toward the posterior.The device was retracted from the incision.The leading haptic unfurled and became positioned correctly upon completely unfolding.The trailing haptic was on the anterior optic surface.A metal instrument was used to push on the iol anterior surface to position.The instrument was then used to gently coax the haptic from the optic surface.The trailing haptic unfolded into the correct position.Product history records were reviewed and the documentation indicated the product met release criteria.A non-qualified viscoelastic was indicated.Based on information provided in the file, the root cause of the leading haptic misfolding during delivery may be related to a failure to follow the ifu.The root cause for the reported pc tear cannot be determined.A non-qualified viscoelastic was indicated.The instruction for use (ifu) instructs: during device preparation and implantation of the company iol with the company preloaded delivery system, an company qualified ophthalmic viscoelastic device (ovd) should be used.The use of an unqualified ophthalmic viscosurgical devices (ovd) may cause damage to the lens and potential complications during the device preparation and implantation steps.The view of the posterior capsule (pc) is slightly blurred as the video appears focused anterior to the pc.While the reported event stating, "the leading haptic tore the posterior capsule," may have been apparent when viewing its occurrence directly through the surgical microscope, this video does not definitively demonstrate a pc tear caused by the leading haptic.Therefore, we cannot confirm the above event based on our review of this video.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
• 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: 16183576
• MDR Text Key: 307480391
• Report Number: 1119421-2023-00115
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652394789
• UDI-Public: 00380652394789
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AU00T0
• Device Lot Number: 15470834
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HEALON
• Patient Outcome(s): Other
• Patient Age: 83 YR
• Patient Sex: Female