MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number ACU0T0

Device Problem Mechanical Jam (2983)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/16/2021

Event Type  malfunction  

Manufacturer Narrative

The device with the lens was returned loose in the opened carton.The plunger lock and lens stop have been removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was retracted to the fill line.The lens had been advanced out of the device and was not returned.The device nozzle tip has stress lines and a long large aneurysm along the left side of device.The nozzle tip has an aneurysm located on the right anterior side and another on the left anterior side.The plunger was removed and evaluated.There was no damage or abnormality observed to the plunger.The plunger was reinserted into the device with no difficulty.The nozzle was removed and cleaned for further evaluation.The lens was removed during cleaning.Top coat dye stain testing was conducted with acceptable results.Product history records were reviewed and documentation indicated the product met release criteria.Viscoelastic information was not provided.It is unknown if a qualified product was used.The root cause cannot be determined for the reported complaint.The plunger position relative to the lens during delivery cannot be confirmed.The plunger was retracted upon return.The tip has stress, a long large aneurysm at the device tip and the two additional tip aneurysms were observed.This damage would indicate the lens/plunger were not in an acceptable position for advancement.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.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 implantation procedure, the intraocular lens (iol) did not come out of injector properly.The patient contact was reported.Additional information has been requested.

• Brand Name: ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM
• Type of Device: LENS, GUIDE, INTRAOCULAR
• 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 ; 8175514979
• MDR Report Key: 12335487
• MDR Text Key: 267022280
• Report Number: 1119421-2021-01579
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 00380652395304
• UDI-Public: 00380652395304
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2024
• Device Model Number: ACU0T0
• Device Lot Number: 15148584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Date Manufacturer Received: 07/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1