MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON ASPHERIC UV ABSORBING IOL WITH AUTONOME DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number CCA0T0

Device Problem Particulates (1451)

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

Event Type  malfunction  

Event Description

A non healthcare professional reported that, the physician noticed what he calls polychromatic sheen on some of the lenses.The physician also added that he was seeing that mostly with specific model of the company lenses.Additionally the physician stated that he noticed this with lenses in the past at another location as well.Additional information was received stating that, the physician noticed it intraoperative - leaving lens implanted.The physician have seen the same thing over the last month in the company lenses as well.The physician also added that he saw this with both the pre-loaded and regular company lenses.None of the patients have any issues with visual acuity.Additionally, the physician also stated that, he did not see this before in months he was using similar company lenses.

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

The product was not returned for analysis.Only photo was returned.Returned photo shows, what appears to be implanted iol.There are reflections of theatre lights on iol optic.The origin of the reported complaint cannot be confirmed from the returned photo.Based on our observation of the attached photo, there are reflections of theatre lights on implanted iol optic.A final root cause cannot be determined based on available information.Based on the results from the product history record, the products met release criteria.

• Brand Name: CLAREON ASPHERIC UV ABSORBING IOL WITH AUTONOME DELIVERY SYSTEM
• Type of Device: INTRAOCULAR LENS
• 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: 17266731
• MDR Text Key: 318463429
• Report Number: 9612169-2023-00514
• Device Sequence Number: 1
• Product Code: HQL
• 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: 09/27/2023

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: CCA0T0
• Device Lot Number: 25623878
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/08/2023
• Initial Date FDA Received: 07/06/2023
• Supplement Dates Manufacturer Received: 08/30/2023
• Supplement Dates FDA Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1