MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE MONARCH IOL DELIVERY SYSTEM, INJECTOR, UNSPECIFIED; LENS, GUIDE, INTRAOCULAR

Model Number ASKU

Device Problems Defective Device (2588); Device Damaged by Another Device (2915)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

A non-healthcare professional reported during intraocular lens (iol) implant procedure, a possible defective loader caused issues with the two lenses.Up on insertion of iol the surgeon stated that the first lens had a tear in lens when in the patient¿s eye and had to be removed and surgeon asked for identical lens and up on insertion of second lens it had 3 tears when in the patient¿s eye and had to be removed.The surgeon swapped the insertion instrument, and also second lens was explanted and replaced with identical third lens during initial procedure without incident.Additional information has been requested.

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

• Brand Name: MONARCH IOL DELIVERY SYSTEM, INJECTOR, UNSPECIFIED
• Type of Device: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer (Section G): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 19141861
• MDR Text Key: 340572955
• Report Number: 2523835-2024-00676
• Device Sequence Number: 1
• Product Code: KYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ASKU
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL; CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL; CLAREON ASPHERIC HYDROPHOBIC ACRYLIC IOL; UNSPECIFIED REPLACEMENT INSERTION INSTRUMENT