MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON VIVITY EXTENDED VISION HYDROPHOBIC IOL W/AUTONOME DELIVERY SYSTEM; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	CNAET0
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been provided in h.3., h.6., and h.11.The product was returned for analysis and straight leading haptic was observed.The device was received in an opened blister tray inside the product carton.Insufficient ovd observed in the device, no ovd past the iol.The lock-out assembly has been removed.The plunger and the lens have been advanced into the mid-nozzle.The plunger position is acceptable.The trailing haptic is folded onto the optic.The leading haptic is extended straight.The complainant indicates the use of non company viscoelastic, which is not qualified for use with associated model, this is not a qualified company product combination.The returned photo shows activated autonome device (nozzle part only).The plunger is advanced into the mid nozzle, appearing to be at the trailing optic edge.The leading haptic is extended straight.The plunger, lens and haptic positions are acceptable.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.While straight leading haptics may occasionally occur, close adherence to the ifu provides the best opportunity for optimal delivery.Possible associated 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 degree c (64 degree f) to 23 degree c (73 degree f).Ovd should be allowed to come to operating room temperature over a 20 minute timeframe prior to use.Any of the above factors alone, or in combination, may lead to an event such as reported.In addition to the above, insufficient viscoelastic was observed in the device.The ifu instructs: fill the device until ovd can be observed flowing to the nozzle tip.This will require approximately 0.28 ml of viscoelastic.If inadequate viscoelastic is placed in the device this will cause inadequate coverage of the lens fold path which may cause the lens to advance incorrectly.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
Additional 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 or Problem Description
A physician reported that during surgery, an anterior haptic was completely bent backwards and twisted.Given that a vivity lens was being implanted, the surgeon preferred to use the second implant (back-up lens) as there was a high risk of damaging the capsule and everything went smoothly.The haptic was completely reversed.Additional information has been requested.

• Brand Name: CLAREON VIVITY EXTENDED VISION HYDROPHOBIC IOL W/AUTONOME DELIVERY SYSTEM
• Common Device Name: EXTENDED DEPTH OF FOCUS 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: 23578994
• Report Number: 9612169-2025-02292
• Device Sequence Number: 9398160
• Product Code: POE
• UDI-Device Identifier: 00380652406369
• UDI-Public: (01)00380652406369(17)290511(11)250513(10)26028576
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2025

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
• Operator of Device: Health Professional
• Device Model Number: CNAET0
• Device Lot Number: 26028576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VISCOELASTIC SOLUTION USED : VYSTHESIA
• Patient Sex: Unknown