MAUDE Adverse Event Report: ALCON LABORATORIES IRELAND LTD. CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	CCWET3
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/29/2022
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 non-healthcare professional reported that during a cataract extraction with intraocular lens (iol) implant procedure, the lens unfolded in the eye with a cracked haptic optic junction.Additional information has been requested and received stated that the lens shattered in the eye, the procedure was completed same day and there was a patient contact.Additional information has been requested.
Additional Manufacturer Narrative
The product was returned for analysis and the reported complaint was observed.Intra ocular lens in sample container of liquid.Solution on iol, one haptic is intact, the other haptic has a crack at the haptic optic gusset.The optic is split in three, one piece is missing.The optic is cracked/fractured and scratched/marked-rejectable.The complainant indicates the use of company handpiece, which is not qualified for use with associated iol 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 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 company 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).
Event or Problem Description
Additional information has been received and stated that surgeon feels techs were loading lens incorrectly, however after inservice with cam, he does not feel it was user error.

• Brand Name: CLAREON VIVITY TORIC EXTENDED VISION UV ABSORBING IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 16052137
• Report Number: 9612169-2022-00727
• Device Sequence Number: 6442448
• Product Code: MJP
• UDI-Device Identifier: 00380652455220
• UDI-Public: 00380652455220
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2023

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: 02/01/2026
• Device Model Number: CCWET3
• Device Catalogue Number: CCWET3.170
• Device Lot Number: 25352289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/30/2022
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 12/27/2022
• Supplement Report FDA Received Date: 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2022
• 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 VISCOELASTIC SYSTEM; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE D; MONARCH III IOL DELIVERY SYSTEM, INJECTOR
• Patient Sex: Unknown