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	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A health care professional reported that during cataract surgery with intraocular lens (iol) implantation, all three iols displayed a tear on the peripheral edge.The patient had to have two lenses explanted in an initial procedure, as the surgeon was not happy with the integrity of the lens and even though the third lens also showed an imperfection the surgeon felt that it would negatively impact the visual outcome for the patient so decided to complete the surgical procedure.Different injectors were utilized for all three lenses being implanted with the same result.Two of the three surgical cases utilized a company d cartridge for lens loading and a company c cartridge was utilized for one case with the same outcome.
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Additional Manufacturer Narrative
The product was returned for analysis and damage was observed to the intraocular lens (iol).Two iol's returned adhered to the outside of a lens case.We can not tell which iol is from what qs.1) solution is dried on the iol.One haptic is broken/torn and is returned, the other haptic is intact.The optic is cracked/fractured and scratched/marked-rejectable.2) solution and blood like substance is dried on the iol.One haptic is broken/torn and is returned, the other haptic is intact.The optic is cracked/fractured and scratched/marked-rejectable with a piece missing.Photo provided shows an implanted iol.There appears to be a scratch/mark/line near the optic edge.The root cause for the reported complaint ¿marks on the peripheral part of the lens¿ could not be determined.The product was subject to handling and the reported damage was highlighted post implantation.The returned iol shows evidence of handling by the customer due to the presence of solution dried on the returned iol.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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 19681045
• Report Number: 9612169-2024-00659
• Device Sequence Number: 6835984
• Product Code: POE
• UDI-Device Identifier: 00380652405300
• UDI-Public: (01)00380652405300(17)270726(11)230728(10)25686847(21)25686847004
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

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: CNWET0
• Device Catalogue Number: CNWET0.230
• Device Lot Number: 25686847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 07/05/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CLAREON MONARCH INJECTOR; MONARCH CARTRIDGE D; MONARCH CARTRIDGE C; MONARCH II LOADING FORCEPS; PROVISC
• Patient Sex: Unknown