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

Model Number CCA0T0

Device Problem Failure to Advance (2524)

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

Event Date 10/12/2023

Event Type  malfunction  

Manufacturer Narrative

A sample device was not returned for analysis.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).

Event Description

A health professional reported that during intraocular lens (iol) implantation procedure, when the iol was half way in the eye, the surgeon could not advance the rest of lens.The surgeon decided to removed the lens.The surgery was completed same day after replacing with same model lens.There was no patient harm.Additional information has been requested.

Manufacturer Narrative

The product was returned for analysis and the reported complaint was observed.The device was returned in the blister tray in the carton.The lock-out assembly has been removed.No ovd observed in the device.The plunger has been advanced outside the nozzle tip and is advanced under the lens.The lens is advanced into the nozzle entry and is crushed.The reporter stated "the surgeon felt that maybe the technician did not have enough viscoelastic in the delivery system".A plunger underride was observed.The root cause may be related to failure to follow the ifu.No viscoelastic was observed in the device.The ifu (instructions for use) instructs: fill the device until ovd can be observed flowing to the nozzle tip.This will require approximately 0.28 ml of viscoelastic.If no viscoelastic is placed in the device this will cause no coverage of the lens fold path which may cause the lens to advance incorrectly or become ¿stuck¿ in the device allowing the plunger to underride the lens.It was also reported that "the surgeon felt that maybe the technician did not have enough viscoelastic in the delivery system ¿based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).

• 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: 18073471
• MDR Text Key: 327403221
• Report Number: 9612169-2023-00767
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652397339
• UDI-Public: 00380652397339
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• 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: 25659993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CLAREON ASPHERIC IOL WITH AUTONOME DELIVERY SYSTEM.; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE.
• Patient Age: 78 YR
• Patient Sex: Female