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

Model Number AU00T0

Device Problem Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Date 09/28/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A facility representative reported that during an intraocular lens (iol) implant procedure, a plunger went off to the side of the lens preventing complete insertion.There was patient contact but no reported patient impact.The surgery was completed the same day.

Manufacturer Narrative

The complaint product is a preloaded device (device with lens).The used device and lens were returned and evaluated.Attempts were made to inquire if listed associated products were a typographical error on the attached form.No clarification was received as to why monarch products were listed.If additional information becomes available that would require an update to this file, the file will be reopened.The device and the lens were returned separately.The device was returned in the opened blister tray inside the carton.The plunger lock and lens stop have been removed.The plunger is oriented correctly.Viscoelastic was observed in the device.The plunger has been retracted to mid-nozzle.No damage was observed to the device.The lens was returned inside a specimen cup.There is no damage observed to the lens.A dimensional inspection (plan view) was conducted.The lens was within the specification per the approved template.The nozzle was removed and cleaned for further evaluation.Top coat dye stain testing was conducted with acceptable results.All product and batch history records are quality reviewed prior to product release.Viscoelastic was not provided.It is unknown if the qualified product was used.The root cause cannot be determined for the reported complaint of ¿plunger went off to the side of the lens preventing complete insertion¿.A plunger override was not observed.The lens and the device were returned separately, indicating that the lens had been delivered through the device.Based on the condition of the lens and device, it is not possible to confirm how the lens delivered from the device tip.No damage was observed to either product.A dimensional inspection (plan view) was conducted.The lens was within the specification per the approved template.It is unknown if a qualified viscoelastic was used.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.Top coat dye stain testing was conducted with acceptable results.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
• Type of Device: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 10714719
• MDR Text Key: 213923707
• Report Number: 1119421-2020-01520
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: AU00T0
• Device Lot Number: 12742757
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/21/2020
• Date Manufacturer Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH III D CARTRIDGE; MONARCH III IOL HANDPIECE; UNSPECIFIED DUOVISC
• Patient Age: 67 YR