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

Model Number SV25T6

Device Problems Scratched Material (3020); Ejection Problem (4009)

Patient Problem Insufficient Information (4580)

Event Date 10/04/2021

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for analysis; the lens remains implanted.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 physician reported that during an intraocular lens (iol) implant procedure, the lens was found to be scratched after implanting.The surgery was completed without product replacement.It was confirmed that the lens became sideways during insertion and was pushed by the plunger in that position, and the surface of the lens got scratched after being implanted into the patient's eye.Also, seems to be a problem at the time of setting, and there was evidence that instead of pushing the edge of the iol optic, the plunger pushed the surface of the optic.Additional information has been requested.

Manufacturer Narrative

Two photos were available in the file for review.Both photos show the lens inside the eye.There are two dark linear areas observed in or on the optic.This appears to be optic damage.It cannot be confirmed if the damage is a scratch or a crack into the optic material.A qualified associated cartridge was indicated.Information was provided that a non-qualified handpiece and non-qualified viscoelastic were used.The root cause of the observed optic damage was most likely due to a failure to follow the instruction for use (ifu).A non-qualified handpiece and non-qualified viscoelastic were indicated.The ifu instructs that an company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.Company recommends using the qualified company iol delivery system or any other company qualified combination.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ RESTOR TORIC SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 12717542
• MDR Text Key: 278995030
• Report Number: 1119421-2021-02025
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: SV25T6
• Device Lot Number: 12595941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2021
• Initial Date FDA Received: 10/29/2021
• Supplement Dates Manufacturer Received: 12/08/2021
• Supplement Dates FDA Received: 12/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MONARCH II INJECTOR; MONARCH III CARTRIDGE D; OPEGAN-HI; MONARCH II INJECTOR; MONARCH III CARTRIDGE D; OPEGAN-HI