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

Model Number	CCWET0
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
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
A facility representative has reported that during a cataract extraction with intraocular lens (iol) implant procedure, a lens unfolded in the eye and had a crack at the haptic/optic junction.The lens was removed during same procedure.Additional information was requested and received, stating the surgeon's opinion that the techs were leading the lens incorrectly, but he does not feel that it was a user error.
Additional Manufacturer Narrative
The product was returned for analysis and the reported complaint was observed.Iol received in a sample container of liquid.Solution on iol.One haptic is intact and the other optic is cracked/fractured at the haptic optic gusset.The optic is torn/split-cut dividing the iol in four and scratched/marked-rejectable.The complainant indicates the use of company cartridge, which are not qualified for use with associated iol model.Used company cartridge is only qualified up to diopter 25.0 for this suspect model.While we are unable to determine the origin of the reported complaint, our observations reasonably suggest that it is not manufacturing related.Based on the information provided by the customer, the most likely root cause is failure to follow instruction for use (ifu), as the surgeon states the use of non-qualified combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.A crack can occur in this section of the iol if the iol is placed incorrectly in the delivery device and/or if the correct dwell time is not adhered to as this can result in stress on the iol as it travels through the delivery device/cartridge resulting in a crack/fracture of the optic.The cartridge ifu instructs: the lens should be inserted until the optic is a little more than half-way inside the cartridge.Use the holding forceps to gently push down on the lens, verifying that the lens is on the bottom surface of the cartridge.Using holding forceps, take the trailing haptic, and gently fold the haptic onto the anterior side of the optic.Slowly grip or push the optic edge to position the lens as far into the cartridge as the forceps will permit, while ensuring the lens remains on the bottom surface of the cartridge and the trailing haptic remains on the optic.It also instructs that prior to loading the iol, the cartridge must be used at operating room temperature of between 18°c and 23°c.Failure to follow these steps may cause the lens to advance incorrectly causing delivery issues and/or damage.The iol ifu instructs: during lens loading and insertion, do not allow the suspect iol to remain in a folded condition within the selected iol delivery system for more than 3 minutes prior to completing insertion into the capsular bag.In addition to this, company foldable iols are qualified for use with a company qualified delivery system and ophthalmic viscosurgical device (ovd) combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.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 VIVITY EXTENDED VISION UV ABSORBING 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: 16494110
• Report Number: 9612169-2023-00190
• Device Sequence Number: 6451732
• Product Code: POE
• UDI-Device Identifier: 00380652405911
• UDI-Public: 00380652405911
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P190018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2023

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 Expiration Date: 02/15/2026
• Device Model Number: CCWET0
• Device Catalogue Number: CCWET0.270
• Device Lot Number: 25357316
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/15/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 05/01/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2022
• 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: DUOVISC; MONARCH III INJECTOR; MONARCH III CARTRIDGE D
• Patient Sex: Unknown