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 Scratched Material (3020)

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

Event Date 09/08/2020

Event Type  malfunction  

Manufacturer Narrative

A sample device was not returned for analysis.Additional information has been requested.The manufacturer internal reference number is: (b)(4).

Event Description

The customer reported that the lens was scratched on side of the optic post implantation.Surgeon said the scratches did not cause visual disturbances, she did not extract the lenses.Additional information was requested.

Manufacturer Narrative

Additional information was provided in d.11, h.3, h.10.Product evaluation: the product was not returned.Complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.A qualified viscoelastic was indicated.The product investigation could not identify a root cause for the reported complaint.Not enough information was provided from the account for further investigation.Additional information was requested.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: 10652628
• MDR Text Key: 211513127
• Report Number: 1119421-2020-01423
• 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: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ACU0T0
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED DISCOVISC OVD