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

Model Number	CCA0T0
Medical Device Problem Codes	Material Deformation (2976); Scratched Material (3020); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Visual Impairment (2138); Insufficient Information (4580)
Date of Event	11/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A product 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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non healthcare professional reported that, after intraocular lens implantation surgery, there was an issue with the implanted lens.The surgeon has planned to explant the lens.Additional information has been received stating that, the day after the surgery it was noted that the lens had 15-20 glistening/"scuff" marks that appeared to be on the front surface of the lens distributed diffusely over the surface.These were not noted on the day of surgery and seemed to appear over night and have not resolved.The surgeon was using non company viscoelastic as a trial.The surgeon also stated that the patient had vision complaints that may or may not be as a result of the lens.The surgeon said the patient prognosis will be good and he was unclear if an explant was necessary at this moment.
Additional Manufacturer Narrative
Additional information provided in h.3., h.6.And h.11.The product was not returned for analysis.Only photos were returned.The reported complaint was observed on the returned photos.Nine images of a dilated eye were provided under varying lighting, focus and magnification.It was reported that, day after surgery it was noted that the lens had 15-20 glistening/scuff marks that appeared to be on the front surface of the lens distributed diffusely over the surface.These were not noted the day of surgery and seemed to appear over night.In several of the images, diffuse white opacifications can be seen as reported.Although it is not possible to definitively determine the location based on the two-dimensional images, if on the surface, this would not be consistent with glistenings which occur in the bulk of the lens and typically would not manifest at one day postoperative or in the involved lens material.The report of possible scuff marks cannot be ruled out based on the resolution of the images, although if present, would have seemingly been observed during the operative procedure and was first observed at one day postoperative.Given the diffuse and somewhat fibrous appearance of the findings, an inflammatory component could be another consideration and potentially consistent with the timing of the appearance.While the source of the observations was not able to be determined based on the images, it was reported that an explant may occur.If performed and an area demonstrating the concern is preserved through the explant procedure and returned, further assessment may be performed.The root cause for the reported complaint could not be determined.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
Additional information was provided in b.2., b.5., d.6.B., d.9., h.3., h.6.And h.11.Correction information was provided in h.6.(fda product code a0415 added).The product, video and photos were returned for analysis and the reported complaint was observed.Intra ocular lens (iol) returned in specimen container immersed in solution.Both haptics are intact.The optic is scratched/marked rejectable.No glistenings observed.The returned video shows, what appears to be an implanted iol.There are light reflections and lines/marks visible over the iol optic.The origin and exact location of the observed marks/lines cannot be confirmed from the returned video.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.We are unable to determine the root cause for the reported complaint "pod 1, lens had 15-20 glistening/"scuff" marks, front surface".The device was not returned.Only the iol was returned.The reported "15-20 glistening/"scuff marks" were not noted the day of surgery and seemed to appear over night.Glistening would not manifest at one day postoperative or in the involved lens material.Given the diffuse and somewhat fibrous appearance of the findings, an inflammatory component could be another consideration and potentially consistent with the timing of the appearance.In regards to the reported "scuff" marks, the lens was returned scratched/marked-rejectable.Lens damage may occur: 1) due to the use of a non-qualified viscoelastic.Lens delivery performance may be negatively affected when using other non-qualified viscoelastics leading to underfill, overfill, misfolding , delivery issues and /or damage.2) 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 and cause delivery issues and /or damage.3) if the operating room temperature is too high (greater than 23 degree celsius / 73 degree fahrenheit) lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement and cause delivery issues and / or product damage.Any of the above listed causes alone, or in combination, may create the reported event.The customer states the use of non-qualified viscoelastic.The use of an unqualified ovd may cause damage to the lens and potential complications during the implantation process.In addition to this, all iols undergo 100 percent cosmetic inspection in accordance with approved manufacturing procedures.Based on the results from the product history record, the products met release criteria.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received stating that the lens was explanted and the sample was received.
Additional Manufacturer Narrative
Corrected information provided in h.6.Correction: on supplemental mdr the result code c0602 should have been submitted.Additional information was provided in b.5.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received stating that the lens was explanted and replaced with another non-company lens.

• Brand Name: CLAREON ASPHERIC UV ABSORBING IOL WITH 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: 21047304
• Report Number: 9612169-2024-01469
• Device Sequence Number: 11582522
• Product Code: HQL
• UDI-Device Identifier: 00380652397148
• UDI-Public: (01)00380652397148(17)280318(11)240320(10)25811549
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/02/2025

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 Model Number: CCA0T0
• Device Lot Number: 25811549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/06/2024
• Supplement Date Received by Manufacturer: 02/24/2025; 03/31/2025; 05/09/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 03/25/2025; 04/30/2025; 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2024
• 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: TOTALVISC OVD LOT: 030487.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male