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 Product Quality Problem (1506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/31/2020

Event Type  malfunction  

Manufacturer Narrative

The lens was not returned.Complaint history and product history and records were reviewed and documentation indicated the product met release criteria.There have been no other complaints reported in the lot number.The product investigation could not identify a root cause.(b)(4).

Event Description

A physician reported, a smooth delivery of a preloaded intraocular lens (iol) into the eye; however the lens showed a "scuff" mark on the side of the optic.This did not cause visual disturbance however the surgeon saw the scuff mark through the microscope.The lens was not extracted.Additional information is requested.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

A qualified viscoelastic was indicated.The product investigation could not identify a root cause for the reported scuff mark.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received; the mark is consistent with previously reported marks on lenses and is reported as not visually significant.

• 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: 10584535
• MDR Text Key: 208804137
• Report Number: 1119421-2020-01311
• 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,Followup
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: ACU0T0
• Device Lot Number: 15069142
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED DISCOVISC OVD, 000545, UNK, BEL