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

Model Number SA60AT

Device Problems Failure to Deliver (2338); Failure to Eject (4010)

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

Event Date 06/29/2021

Event Type  malfunction  

Manufacturer Narrative

The product was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.The file indicates the use of a qualified cartridge.The file does not indicate what handpiece was used.Two viscoelastics were indicated, only one is qualified for this lens with the qualified cartridge and handpiece combinations.The product investigation could not identify a root cause for the reported.Information was provided that the reason for the iol being stuck in the cartridge was likely due to user error.The manufacturer internal reference number is: (b)(4).

Event Description

A nurse reported that, during intraocular lens (iol) implantation, the iol got stuck in the cartridge.Doctor was unable to successfully deploy the iol, part of the iol was stuck in the cartridge, which was unable to release.Doctor then remove the lens and implanted another lens.Patient treated as intended.

Manufacturer Narrative

(b)(4).The lens was returned loose in a bag inside the carton.The lens case was also returned.A small amount of viscoelastic is observed on the lens.A small scratch is observed on the anterior optic surface near the edge.This damage is similar to damage caused by an instrument used to grasp the lens.It is unknown of a qualified product was used.The root cause for the reported complaint of iol stuck in the cartridge could not be determined.The lens was not returned in the reported condition.The ifu instructs: company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.The ifu also instructs to completely fill the cartridge with ovd (diagram provided) immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF SINGLEPIECE 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 ; 8175514979
• MDR Report Key: 12239803
• MDR Text Key: 263870786
• Report Number: 1119421-2021-01485
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652555838
• UDI-Public: 00380652555838
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SA60AT
• Device Catalogue Number: SA60AT.215
• Device Lot Number: 15167538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DUOVISC VISCOELASTIC SYSTEM; MONARCH II IOL DELIVERY SYSTEM, CARTRIDGE B