MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON TORIC IOL; LENS, INTRAOCULAR, TORIC OPTICS

Lot Number ASKU

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 05/02/2022

Event Type  malfunction  

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).

Event Description

A non-healthcare professional reported that during an intraocular lens (iol) implant procedure, a plastic slivers stuck to the lens after implantation through a cartridge.There were no patient complications resulting from this foreign body material.The plastic slivers were removed.There are five medical device reports associated with this event.This is 1 of 5.Additional information was requested.

Manufacturer Narrative

The product was not returned for analysis.The reporting facility did not provide a lot number or any identification of the product.Photo review: photo provided showing an implanted intraocular lens (iol) on a monitor screen.There is what appears to be a piece of foreign material on the optic.Based on our observation of the attached photo, foreign material is on the optic.A definitive determination of complaint cannot be made without the evaluation of the physical product.A final root cause cannot be determined, based on available information.All product and batch history records are quality reviewed, prior to product release.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON TORIC IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer (Section G): ALCON LABORATORIES IRELAND LTD.; cork business&technology park; model farm road; cork 00000 ; EI 00000
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 14564783
• MDR Text Key: 293080603
• Report Number: 9612169-2022-00243
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P190018
• 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: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MONARCH III CARTRIDGE D