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 Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The device with the lens was returned loose in the carton.The plunger lock and lens stop have been removed.Upon return, the plunger was oriented incorrectly.Viscoelastic was observed in the device.The plunger was at the trailing optic edge.The lens was inside the nozzle area.The trailing haptic was misfolded, twisted and positioned on the optic.Product history records were reviewed and documentation indicated the product met release criteria.Viscoelastic was not provided.It is unknown if the qualified product was used.The root cause cannot be determined for the reported issue of ¿fault with the iol¿.The used device was inspected.The trailing haptic was misfolded.It is unknown if the qualified viscoelastic was used.Material properties of non-qualified viscoelastic devices may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.Upon return, the plunger was observed to be oriented incorrectly in the device.It cannot be determined if the plunger may have been inadvertently retracted outside of the device and reinserted incorrectly by the customer.(b)(4).

Event Description

A healthcare professional reported a "fault" with the intraocular lens (iol) during an implantation procedure.An alternate lens was used to complete the procedure.Additional information is not available from the facility for this reported event.

• 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: 11013961
• MDR Text Key: 222025576
• Report Number: 1119421-2020-01931
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/15/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2023
• Device Model Number: ACU0T0
• Device Lot Number: 15060552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2020
• Initial Date FDA Received: 12/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1