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

Model Number	CNA0T0
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Codes	Inflammation (1932); Intraocular Pressure Increased (1937); Retinal Detachment (2047); Blurred Vision (2137); Capsular Bag Tear (2639)
Date of Event	11/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that during an intraocular lens (iol) implant procedure, the haptic was positioned like a (superman) straight forward leading haptic, causing the capsular bag to rupture.The lens was not explanted but the patient will see the retinologist for advice and follow-up.Additional information has been received that patient experienced moderate hypertonia.The anterior vitrectomy was done on the same day of implant procedure and posterior vitrectomy was done 8 days later because of traction on traction on retina.The visual acuity was 2/10 and eye had inflammation.In surgeon opinion immediate tearing of the sac given the fragility of the tissues and the haptic came out twisted caused the capsular bag rapture.
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).
Additional Manufacturer Narrative
Correction information was provided in h.6.- patient code 2639 was not reported in initial mdr reported.The product was not returned for analysis.The root cause for the reported complaint could not be determined as no sample was returned for analysis.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
• Common Device Name: 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: 18204262
• Report Number: 9612169-2023-00824
• Device Sequence Number: 17992537
• Product Code: HQL
• UDI-Device Identifier: 00380652393645
• UDI-Public: 00380652393645
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/02/2026
• Device Model Number: CNA0T0
• Device Lot Number: 25618935
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2023
• Supplement Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 11/24/2023
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 66 YR
• Patient Sex: Female