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

Model Number SA60WF

Device Problems Device Damaged by Another Device (2915); Failure to Eject (4010)

Patient Problem Insufficient Information (4580)

Event Date 09/23/2022

Event Type  malfunction  

Event Description

A nurse reported that during a cataract extraction with intraocular lens (iol) implant procedure, the lens was damaged during implantation and was stuck in the injector, the lens was replaced in the initial procedure and the procedure was completed without affecting the course of the operation.The defect was detected during the procedure.Additional information has been requested.

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.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The lens was returned advance between the loading area and the nozzle entry area in a qualified company cartridge.An inadequate amount of viscoelastic is observed in the cartridge (ovd visible in the tip only).The lens is in an acceptable folded position.No damage observed.The cartridge shows evidence it was placed into a handpiece.No tip damage observed.The file indicated the use of a qualified company cartridge with an company handpiece.The associated viscoelastic was not provided.It is unknown if a qualified product was used.The reported lens damage could not be confirmed.The specific lens damage was not provided.The root cause for the reported "stuck in the injector" may be related to a failure to follow the instruction for use (ifu).An inadequate amount of viscoelastic was observed in the cartridge.The ifu 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 and/or delivery issues.Per the device (direction for use) dfu: the qualified cartridge/iol combinations have been validated at an ambient temperature of 18 °c using the driving console setting (1.7 mm/sec, 3 seconds, and 3.0 mm/sec for initial velocity, pause and final velocity respectively).Using a higher velocity and shorter pause at lower temperatures, especially with high diopter lenses, could induce damage to iol and/or iol cartridge, affecting successful iol implantation.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF ASPHERIC UV ABSORBING 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: 15647452
• MDR Text Key: 303553086
• Report Number: 1119421-2022-02238
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652332699
• UDI-Public: 00380652332699
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.215
• Device Lot Number: 15334211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: INTREPID AUTOSERT IOL HANDPIECE; MONARCH, CARTRIDGE D