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

Model Number CNA0T0

Device Problem Device Damaged by Another Device (2915)

Patient Problems Rupture (2208); Swelling/ Edema (4577)

Event Date 02/14/2022

Event Type  Injury  

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 healthcare professional reported during an intraocular lens implant procedure, the haptic torn off during implantation and ruptured the posterior capsule.The lens was exchanged with another lens during the initial procedure.The patient was tested visual acuity of the order of 0.7, there is a slight swelling in the corneal zone, in the projection of the main access.Additional information has been requested.

Manufacturer Narrative

The product was not returned for analysis.Photo provided shows fully activated intraocular lens (iol) device, no damage can be confirmed from the photo.Photo also shows iol on the iol case lid.The haptic is observed broken/ torn and is present in the photo.Based on our observation of the attached photo, haptic is broken/torn.A definitive determination of damage cannot be made without the evaluation of the physical product.A final root cause cannot be determined based on available information.Broken haptics may occur: ¿ due to the use of a non-qualified viscoelastic.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.¿ if the operating room temperature is too high (> 23°c / 73° f) lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement.In addition, haptic strength (modulus) decreases as the temperature increases and is more likely to break under stress.¿ if a straight trailing haptic occurs and it was not properly detected to be out of position.¿ if the plunger is not fully advanced, the trailing haptic may not release properly from the device.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.There are no other complaints for the reported lot.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: 13693292
• MDR Text Key: 286757470
• Report Number: 9612169-2022-00105
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380652393607
• UDI-Public: 00380652393607
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: P190018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2024
• Device Model Number: CNA0T0
• Device Lot Number: 25138553
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DUOVISC VISCOELASTIC SYSTEM
• Patient Outcome(s): Other
• Patient Age: 72 YR