MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON IOL; INTRAOCULAR LENS

Model Number	SY60WF
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A surgeon reported that following an intraocular lens (iol) implant procedure, it was noted that lens had glistening and opacity that may require explantation.The surgeon will see the patient again the following week.Additional information has been requested, received and stated lens explantation has be decided, but not done yet.Additional information has been requested, received and stated lens explantation has be done.Quantification of the glistening (tyndall analogy) showed 3+ constant over time, but less peripheral opacification on explantation 1+ and the same for haptics.
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
The product was returned for analysis and the reported "glistenings and opacity" were not observed.Intraocular lens (iol) returned in 2 segments inside a sample container.The iol segments are immersed in solution.One haptic is broken/torn and is returned, the other haptic is intact.The optic is cracked/fractured and scratched/marked-rejectable.No glistenings observed.Photo review: email with new information from surgeon: this communication contains three distinct photographs.The first photograph is of an iol though an undilated pupil focus on the anterior portion of the lens.There appears to be moderate to dense reflective material through out the entire lens within the slit beam.The second photograph is better focused on the anterior lens and it appears to be a denser reflective ¿material¿ on the anterior surface of the lens.The focus of the beam does not allow for evaluation of anything beyond the anterior lens surface.The glare from the third photograph makes it difficult to determine anything from the photograph.It is difficult to determine with certainty what is causing this rather dense opacification on the anterior surface of the lens.Glistening are fluid filled microvacuoles observed on the optic of an iol when it is in an aqueous environment.They are observed as reflections of light originating from the migration of water within the matrix of a hydrophobic acrylic material.Other possible causes for this condition include debris from the breakdown of the blood-aqueous barrier (e.G.Higher serum components in the aqueous with diabetes and exposure to active ingredients in topical medications).The root cause for the reported complaint could not be determined.Based on the results from the product history record, the product met release criteria.The manufacturer internal reference number is: (b)(4).

• Brand Name: CLAREON IOL
• 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: 18675032
• Report Number: 9612169-2024-00106
• Device Sequence Number: 6156212
• Product Code: HQL
• UDI-Device Identifier: 00380652251402
• UDI-Public: 00380652251402
• 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: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2024

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: 08/27/2026
• Device Model Number: SY60WF
• Device Lot Number: 25478380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/17/2024
• Supplement Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2022
• 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: DL-LYSINE ACETYLSALICYLATE.; DORZOLAMIDE.; LATANOPROST.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female