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

Model Number SN6AT4

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

Patient Problem Insufficient Information (4580)

Event Date 03/08/2022

Event Type  malfunction  

Event Description

A non-health care professional reported during the intraocular lens implantation debris was noted on the intraocular lens after it was implanted into the eye.The lens was removed and replaced with a back up lens of the same model and diopter.No vitrectomy, suture of lens or incision or incision enlargement was needed.Capsule bag was intact.Additional information has been requested.

Manufacturer Narrative

The lens was returned in the lens case.Viscoelastic with what appears to be blood was visible on the lens.The lens was cut into two pieces across the center of the optic.One haptic tip was torn/scraped.The material from the damaged area may have been interpreted as the reported foreign material.No foreign material was observed on either haptic or the lens portions.Product history records were reviewed and documentation indicated the product met release criteria.Qualified associated products were indicated.One haptic tip was torn/scraped.The material from the damaged area may have been interpreted as the reported foreign material.No foreign material was observed on either haptic or the lens portions.The root cause for the observed haptic damage could no be determined.The damage may have occurred during loading or advancement in the cartridge.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met company release criteria.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
• 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: 14250879
• MDR Text Key: 290393709
• Report Number: 1119421-2022-00905
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 00380652250481
• UDI-Public: 00380652250481
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SN6AT4
• Device Catalogue Number: SN6AT4.230
• Device Lot Number: 15084904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2022
• Date Manufacturer Received: 04/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DISCOVISC.; MONARCH III CARTRIDGE D.; MONARCH III IOL INJECTOR.; ORA SYSTEM WITH VERIFEYE.
• Patient Age: 77 YR
• Patient Sex: Female