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 Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2019

Event Type  malfunction  

Manufacturer Narrative

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 has been one other complaint reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse coordinator reported that during an intraocular lens (iol) implant procedure, the plunger in a preloaded device did not push the lens properly to end of shooter and went past lens.There was patient contact, but no patient harm.The procedure was completed the same day.

Manufacturer Narrative

Product evaluation: the device with the lens was returned loose in the opened carton.The plunger lock and lens stop have been removed.The plunger is oriented correctly.Viscoelastic is observed in the device.The plunger has slightly retracted from the lens at mid-nozzle.The leading haptic and the trailing haptic were both folded onto the anterior optic surface.A plunger override was not observed upon return.The nozzle was cleaned for further evaluation.The lens was removed during cleaning.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 is at mid-nozzle with both haptics properly folded onto the optic surface.A plunger override was not observed upon return.The position of the plunger relative to the lens cannot be verified because the plunger was retracted from the optic upon return.Top coat dye stain testing was conducted with acceptable results.Additional information provided in h.3., h.6.And h.10.The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: 9703230
• MDR Text Key: 182990799
• Report Number: 1119421-2020-00224
• 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: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: AU00T0
• Device Lot Number: 12556590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Date Manufacturer Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED DUOVISC VISCOELASTIC
• Patient Age: 57 YR