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

Model Number SA60AT

Device Problems Defective Component (2292); Failure to Eject (4010)

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

Event Date 06/26/2023

Event Type  malfunction  

Event Description

A healthcare professional reported that during an intraocular lens (iol) implant procedure, the lens was stuck with plunger and surgeon tried to pull out and cause haptic broken.The lens was explanted during initial procedure.The surgery was completed with backup lens without complication.

Manufacturer Narrative

A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The lens was returned in the loading area of a qualified company cartridge.An insufficient amount of viscoelastic was observed in the cartridge.One haptic was broken in the gusset area (not returned).The cartridge does have slight evidence that it was placed in a handpiece.No tip damage observed.Product history records were reviewed and the documentation indicated the product met release criteria.A qualified cartridge and handpiece were used.A non-qualified viscoelastic was indicated.Based on the provided information, the root cause is most likely related to a failure to follow the ifu.A non-qualified viscoelastic was used.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 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.In addition, an inadequate amount of viscoelastic was observed in the cartridge.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 delivery issues or damage.The cartridge shows evidence it was placed into a handpiece, but not fully seated.The ifu instructs the user to insert the cartridge into the handpiece and fully slide the cartridge forward into the handpiece locking slots.The cartridge did not appear to have been fully seated in the handpiece.This could have caused the lens to deploy incorrectly or the plunger to be misaligned during advancement which could result in delivery issues and or product 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 ; 8007579780
• MDR Report Key: 18335197
• MDR Text Key: 330602389
• Report Number: 1119421-2023-02161
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652555845
• UDI-Public: 00380652555845
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: P930014
• 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: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• 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.220
• Device Lot Number: 15509229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DUOVISC VISCOELASTIC SYSTEM; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Patient Sex: Male