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

Model Number	CNWET0
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2023
Type of Reportable Event	Serious Injury
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
An ophthalmic surgeon reported that during a cataract extraction with an intraocular lens (iol) implant procedure, the lens was found to be scratched.Additional information was received stating crack was noted on intraocular lens after insertion, hence cracked one was removed during initial procedure.New iol was implanted.There was no patient harm reported.Surgery was completed on the same day.There are four medical device reports associated with this complaint.This report is 3 of 4.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6., h.10.The product was returned for analysis and the reported complaint was observed.Iol returned positioned incorrectly in the iol case.Solution is dried on both surfaces of the optic and haptics.Both haptics are intact.The optic is cracked/fractured splitting the iol in two and scratched/marked-rejectable.An additional small crack can be seen on the optic edge.We are unable to determine the root cause for the reported complaint " cracked noted after insertion ".The returned iol shows evidence of possible handling by the customer due to the presence of solution dried on both surfaces of the optic and haptics.The product was subject to handling as the reported damage was highlighted post implantation.In addition to this, all iols are 100% cosmetically inspected as per approved manufacturing procedures and the observed damage would not meet our current release criteria.Based on these investigation findings, we are unable to verify if the iol contributed to the event.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
A sample device 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
Additional information was received stating that medical intervention like incision enlarged was required to complete the procedure.There was no patient harm reported.There are four medical device reports associated with this complaint.This report is 3 of 4.

• Brand Name: CLAREON VIVITY EXTENDED VISION HYDROPHOBIC IOL
• 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: 16896634
• Report Number: 9612169-2023-00357
• Device Sequence Number: 6162843
• Product Code: POE
• UDI-Device Identifier: 00380652405232
• UDI-Public: 00380652405232
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/12/2023

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: 02/08/2026
• Device Model Number: CNWET0
• Device Catalogue Number: CNWET0.195
• Device Lot Number: 25357511
• 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: 04/20/2023
• Supplement Date Received by Manufacturer: 07/05/2023; 09/15/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 07/31/2023; 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2022
• 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: LARGE TIER FORCEPS.; MONARCH III, CARTRIDGE D.; MONARCH III, INJECTOR.; PROVISC.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female