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

Model Number SN6AT3

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Insufficient Information (4580)

Event Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The 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 physician reported that during multiple cataract surgeries with an intraocular lens (iol) implantation on the same day, there was foreign material like a fiber found on the back side of the iols after insertion.In the facility, the surgeon implants iols by wound-assisted method with cornea incision 2.4 mm; therefore, he would like to know whether there is a possibility that the cells close to the incision point had got into the eye.In all cases, the surgery was completed without product replacement after the removal of foreign material.The iol samples are not available as the iols remain implanted.Additional information was provided indicating that there were actually eight events on the same day with different lens models.This medical device report is for the 6th of 8 cases.

Manufacturer Narrative

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

Manufacturer Narrative

Evaluation summary: the lens and foreign material were not returned for evaluation.A video was provided.The cartridge preparation was not shown.There appeared to be adequate viscoelastic as the lens was advanced.The lens was loaded with a pair of narrow tip forceps grasping the lens across the center of the optic.The lens was rapidly advanced using what appear to be a loading forceps held sideways.The lens is quickly delivered.As the lens is dialed into place, a strip of material is observed on the posterior surface of the optic.The material is removed with the irrigation aspiration (i/a) tip.The lens remains implanted.The iol product history records were reviewed and documentation indicated the product met release criteria.The indicated associated cartridge is qualified for use with the lens.A nonqualified handpiece/viscoelastic combination was indicated.The root cause for the reported issue could not be determined.The lens and foreign material were not returned for evaluation.The lens remains implanted.Foreign material was observed on the provided video.The nature of the material could not be determined from the video.The material was quickly removed with the i/a tip.The manufacturer internal reference number is: (b)(4).

• 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: 10819785
• MDR Text Key: 217147194
• Report Number: 1119421-2020-01663
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: SN6AT3
• Device Catalogue Number: SN6AT3A110
• Device Lot Number: 12699482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AE-9036SP; MONARCH III D CARTRIDGES, 8065977763, HWV; OPEGAN