MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF MULTIPIECE IOL; INTRAOCULAR LENS

Model Number MA60AC

Device Problem Failure to Unfold or Unwrap (1669)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/31/2022

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for analysis.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 non-healthcare professional reported that during the cataract surgery with intraocular lens implant procedure, haptic didn't open when placed in eye.There was patient contact noted.Additional information has been received and stated that, it was unknown if leading or trailing haptic issue however there was no patient harm reported.

Manufacturer Narrative

Information was provided that indicated the use of a qualified handpiece and two viscoelastics.A non-qualified company cartridge was indicated.The company intraocular lens (iol) model is only qualified for use in the company cartridges.The root cause for the reported complaint was most likely related to a failure to follow the ifu.A non-qualified cartridge was used.The instruction for use (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 MULTIPIECE IOL
• Type of Device: INTRAOCULAR LENS
• 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: 15887164
• MDR Text Key: 307678585
• Report Number: 1119421-2022-02526
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652552523
• UDI-Public: 00380652552523
• 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,Followup
• Report Date: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MA60AC
• Device Catalogue Number: MA60AC.200
• Device Lot Number: 15102359
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DUOVISC; MONARCH CARTRIDGE D; MONARCH INJECTOR