MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR; FOLDERS AND INJECTORS , INRAOCULAR LENS (IOL)

Model Number IV

Device Problem Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 12/05/2022

Event Type  malfunction  

Event Description

A non-healthcare professional reported that during a cataract extraction with an intraocular lens (iol) implant procedure, the plunger found to be bent.Additional information was received stating plunger was noticed when advanced lens that it was over riding the lens and then when compared to another injector the tip of the plunger appeared bent slightly.Procedure was completed on the same day.

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

One opened handpiece was received for the report of bent plunger.The returned sample was visually inspected and found to be conforming.A functional thread engagement and plunger movement test was performed and found to be conforming.Finally, the plunger height was dimensionally inspected and found to be conforming.A review of the device history record traceable to the reported lot number indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.A complaint history examination for device component lot traceable to the reported lot number indicates there are two additional complaints associated with the component lot for the reported issue.A non-conformance search for the component lot numbers traceable to the reported lot number indicates there are no non-conformances associated with the lot for the reported issue.The returned sample was found to be conforming for all visual and dimensional inspections, and functional tests, associated with the reported event, therefore a bent plunger as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON MONARCH IV IOL DELIVERY SYSTEM, INJECTOR
• Type of Device: FOLDERS AND INJECTORS , INRAOCULAR LENS (IOL)
• 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: 16060269
• MDR Text Key: 306594397
• Report Number: 2523835-2022-00496
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IV
• Device Catalogue Number: 8065977774
• Device Lot Number: 145HDJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 12/07/2022
• Initial Date FDA Received: 12/28/2022
• Supplement Dates Manufacturer Received: 03/08/2023
• Supplement Dates FDA Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ANIKAVISC; MONARCH III, CARTRIDGE C; UNSPECIFIED FORCEPS