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 Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Results from the product history record review indicated the product met release criteria.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that during an intraocular lens (iol) implant procedure, the iol was stuck in the shooter, then stuck in the incision.The lens was inserted and then removed from the eye.Additional information was provided indicating that the procedure was completed.There was no patient harm.In the surgeon's opinion the cause or contributor of the event is unknown.

Manufacturer Narrative

Additional information was provided in h.3., h.6.And h.10.Evaluation summary: the device and the lens were returned inside a self seal pouch.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger has been advanced and the tip extends beyond the device.No damage was observed to the device.The lens was returned adhered in dried solution to the exterior of the lens loading door.The lens was positioned posterior surface up.One haptic is bent with the distal tip adhered in dried solution to the optic anterior surface near the optic edge.The nozzle was 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.A qualified viscoelastic was used.The root cause cannot be determined for the complaint.The lens was returned outside the device.No damage was observed to the device.The plunger upon return was slightly retracted.It is unknown if the plunger was fully advanced during the lens delivery attempt.The manufacturer internal reference number is: (b)(4).

• 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
• MDR Report Key: 9854542
• MDR Text Key: 186147534
• Report Number: 1119421-2020-00467
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: ACU0T0
• Device Lot Number: 12611643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Date Manufacturer Received: 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED PROVISC OVD.
• Patient Age: 69 YR