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 Component (2292); Device Damaged by Another Device (2915); Failure to Eject (4010)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

A non-healthcare professional reported that during an intraocular lens (iol) implant procedure, the company injectors were damaging the lens the plunger were extremely loose and can cause it to ride over top of lenses.Additional information received by physician stated that the 'pushing' part of the company injector often will slide over the top of the lens, not catching it at the edge of the optic, causing the lenses to be scratched and even cutting the optic or haptic.The 'screw' part of the injector was very unstable and poorly secured, so it was very unpredictable how the lens will be advanced down the cartridge." they have 4 company injectors and 6 other company injectors, and both have the history of sliding over the top of the lens and scratching the lens.No further information available.

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).

Manufacturer Narrative

A sample was not received, at the manufacturing site for evaluation.For the report of damaging lenses, over riding, and loose plunger.Therefore, the condition of the product could not be verified.A photo of product is attached to the parent file.And has been reviewed by the investigation site.The photo is of a superior surgical injector.This is not a company product and not associated with the file.Per the follow-up information, this file also encompasses "4 silver company injectors".No lot number was identified with this complaint.Therefore, a device history record review could not be conducted.A sample was not received, at the manufacturing site.And no lot information is available.Therefore, the root cause for the customer complaint issue cannot be determined.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: 14447772
• MDR Text Key: 292204676
• Report Number: 2523835-2022-00177
• 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
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• 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: 07/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; SUPER SURGICAL INJECTORS