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

Model Number AU00T0

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 01/04/2021

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis. The product history and batch records were reviewed and documentation indicated the product met release criteria. A qualified viscoelastic was indicated. The product investigation could not identify a root cause. There have been no other complaints reported in the lot number. The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported that during an intraocular lens (iol) implantation procedure, the trailing haptic appeared to be sliced. Approximately 60% of it. As the lens was unfolding inside the eye, there was noted to be a defect in the trailing haptic. The defect was a partial thickness slice in the haptic. The surgeon's prognosis is good. Additional information was provided indicating that because of covid related issue, the surgeon did not perform a post-operative, dilated exam on this patient until recently. The implant is subluxed superiorly to a mild-moderate degree. This is undoubtedly related to the damaged haptic. Fortunately, the visual acuity is unaffected, and the patient is doing very well.

• 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: 11780758
• MDR Text Key: 249284051
• Report Number: 1119421-2021-00959
• Device Sequence Number: 1
• Product Code: KYB
• 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
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 05/05/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: AU00T0
• Device Lot Number: 15100919
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2020
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial