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

Model Number CNA0T0

Device Problems Defective Device (2588); Device Dislodged or Dislocated (2923)

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

Event Date 09/30/2022

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.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

A pharmacist reported that during implantation of an intraocular lens (iol) the implant was badly positioned in the injector and that the haptic was taken out of the injector instead of being folded on the implant.This caused the haptic to be placed in the wrong direction in the patient's eye and required several manipulations to reposition the implant.Untimely maneuvers to reposition haptic of the implant in the capsular bag were necessary to reposition the implant correctly.No clinical consequences were noted additional information was requested and received stating the affected eye was left eye.

Manufacturer Narrative

The product was returned for analysis and the reported complaint could not be confirmed.The device was returned in a clear plastic bag.The lock-out assembly has been removed.The plunger is oriented correctly.The plunger has been fully advanced outside the tip of the device.Viscoelastic is dried in the device.No damage or abnormalities observed.No lens returned.Haptic position for the advancement cannot be confirm.Only the device is available for evaluation.No damage was observed to the device.The presentation of straight leading haptics is addressed in the product instructions for use (ifu) where it is provided that delivery may proceed with caution and should be managed based on the outlined instructions.Straight leading haptics may occasionally occur, close adherence to the ifu provides the best opportunity for optimal delivery.Possible associated root cause factors may also include: *use of a non-qualified viscoelastic or bss in the delivery system.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.*excessive delay between device preparation and subsequent delivery resulting in the potential for haptic unfolding.*use of the delivery system at operating room temperatures outside of the recommended range of 18 °c (64 °f) to 23 °c (73 °f).Ovd should be allowed to come to operating room temperature over a 30 minute timeframe prior to use.Any of the above listed causes alone, or in combination, may create the reported event.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 IOL WITH THE 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: 15697768
• MDR Text Key: 302700599
• Report Number: 9612169-2022-00562
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652393744
• UDI-Public: 00380652393744
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P190018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 01/06/2023

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: CNA0T0
• Device Lot Number: 25433107
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/26/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2022
• Initial Date FDA Received: 10/31/2022
• Supplement Dates Manufacturer Received: 12/13/2022
• Supplement Dates FDA Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PROVISC
• Patient Age: 78 YR
• Patient Sex: Female