MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number SN6AT6

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Blurred Vision (2137); Visual Impairment (2138)

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.Product history and batch records were reviewed and documentation indicated the product met release criteria.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 facility representative reported that after an intraocular lens (iol) was implanted the patient "struggles with clarity and blurry vision" and is "unable to function with anisometropia.A lens exchange is planned.Additional information has been requested, however, has not been received.

Manufacturer Narrative

Additional information provided in b2., b5 and h10.Based on information received following submission of the initial report, this event does not meet criteria for reporting as a serious injury as the surgeon indicated the patient's issues have resolved and the event occurred due to a calculation issue.The manufacturer internal reference number is: (b)(4).

Event Description

Updated information from the reporter indicated that the patient's issues have resolved and the event occurred due to a calculation issue.This event no longer meets criteria for reporting based on applicable medical device regulations.

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 10950423
• MDR Text Key: 219883932
• Report Number: 1119421-2020-01834
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: SN6AT6
• Device Catalogue Number: SN6AT6U205
• Device Lot Number: 12378904
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other