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

Model Number AU00T0

Device Problems Material Twisted/Bent (2981); Failure to Eject (4010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/28/2021

Event Type  malfunction  

Event Description

A surgeon reported that during an intraocular lens (iol) implant surgery, the plunger did not push the lens through the haptic, it had pushed through the optic area, causing the second haptic to come out strange and almost out of the eye.It was also report that the lens was implanted with a little manipulation.The injector did not drag the lens well.No further information is expected.

Manufacturer Narrative

A sample device was not returned for analysis.Complaint and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There has been other complaint in the lot reported.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
• 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: 12883427
• MDR Text Key: 281334812
• Report Number: 1119421-2021-02253
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 00380652394802
• UDI-Public: 00380652394802
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AU00T0
• Device Lot Number: 15239963
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1