MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. ACRYSOF IQ TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number SN6AT3

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Visual Disturbances (2140)

Event Date 11/05/2021

Event Type  malfunction  

Manufacturer Narrative

A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A medical engineer reported that following an intraocular lens (iol) implant procedure, the patient experienced glare and other visual side effects.The slit lamp images and the pentacam images show glistening's.Diagnosed with glimmer vision.The patient issue was not resolved.There are two medical device reports associated with this event.This report is associated with the right eye.Additional information has been requested; however, further information has not been received.

Manufacturer Narrative

Four images were submitted and reviewed.Both od and os slit lamp images are optic sections illuminating the center of the intraocular lens (iols) through dilated pupils.The images show what appear to be diffuse refractile bodies within the iols.The corresponding od and os pentacam images also demonstrate the presence of the refractile bodies appearing to be within the bulk of the iols consistent with microvacuoles such as associated with glistenings.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received and stated that, explanation has not yet been performed and according to the patient they have not yet planned.

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 12927536
• MDR Text Key: 281752525
• Report Number: 9612169-2021-00283
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 00380652249898
• UDI-Public: 00380652249898
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: SN6AT3
• Device Catalogue Number: SN6AT3.200
• Device Lot Number: 21107096
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR