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

Model Number AU00T0

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dry Eye(s) (1814); Visual Impairment (2138)

Event Date 12/17/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A patient reported, two weeks following intraocular lens implant he could not see clear and noted things to look antique white out of the right eye.Additional information received; the patient reported the symptoms are persisting.One day following surgery a drop for dryness, a hydrating and lubricating emulsion was begun three times a day along with a corticosteroid six times a day.Five days later the hydrating and lubricating emulsion was decreased to two times a day and the corticosteroid was decreased to four times a day and put on a taper.The patient is pending further follow up.

Manufacturer Narrative

Additional information provided in h.3, h.6, and h.10.The product was not returned for analysis.The 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.The viscoelastic information was not provided.It is unknown if a qualified product was used.The product investigation could not identify a root cause for the reported complaint.Not enough information was provided from the account for further investigation.The consumer did not want to provide the lot and serial numbers.No further information has been provided.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11258641
• MDR Text Key: 229622817
• Report Number: 1119421-2021-00205
• Device Sequence Number: 1
• Product Code: HQL
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AU00T0
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention