MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ VIVITY EXTENDED VISION IOL; INTRAOCULAR LENS

Model Number	DFT015
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
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 physician reported that during an intraocular lens (iol) implant procedure, after implantation of company lens, a significant crack was detected.Subsequently the lens was explanted and operation was completed but patient left aphakic.Additional information has been requested.
Additional Manufacturer Narrative
Additional information was provided in h.3.,h.6 and h.11.A photo was provided of an implanted single-piece lens.A crack was visible near the center of the optic.The crack was angled to the travel path.This may indicate a plunger override occurred.The account indicated the use of a qualified associated cartridge and handpiece with a non-qualified viscoelastic.Based on our observation of the attached photos, the lens is cracked.The root cause for the reported complaint may be related to a failure to follow the instruction for use (ifu).The viscoelastic indicated is not qualified for the lens or company combination used.The ifu instructs that an company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.The product has not been received to evaluate.It is difficult to make a final determination without evaluation of the physical sample.Due diligence has been performed in an attempt to obtain further information on this event.File will be reopened if new information or the sample is received.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Additional information was provided in d.9.,h.3.,h.6 and h.11.The lens was returned positioned incorrectly in the lens case.Blood and solution was dried on the lens.One haptic was broken in the gusset area (not returned).The optic was cut into pieces, typical of insertion and removal.The cut optic portions have multiple cracks and deep scrape marks on the anterior and posterior sides of the lens.One large crack near the cut damage in the center of the lens was angled to the travel path.This may indicate a plunger override occurred.The photo provided appears to be of the returned sample.Product history records were reviewed and the documentation indicated the product met release criteria.The file indicated the use of a qualified associated cartridge and handpiece with a non-qualified viscoelastic.The reported lens damage was observed.The root cause for the reported complaint may be related to a failure to follow the instructions for use (ifu).The viscoelastic indicated is not qualified for the lens/monarch combination used.The ifu instructs: company foldable intra ocular lens (iols) are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that an company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.The ifu instructs: using holding forceps, grasp the lens by the optic edge and gently place the lens anterior side up into the back of the ovd filled cartridge.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.Failure to follow these steps may cause the lens to advance incorrectly causing delivery issues and or damage.Important: the plunger should make initial contact with the cartridge at the ramp.In the event the plunger does not contact the cartridge at the ramp, do not use the handpiece and contact company.The handpiece ifu instructs: verify that the plunger tip is properly engaging the lens optic and that the lens moves forward at the same rate as the plunger while slowly advancing the plunger forward to avoid damaging the lens.When the threads on the knob make contact with the barrel, turn the knob clockwise approximately half turn to engage the threads and then stop.The iol will now be in the dwell position.Inspect to ensure the plunger is behind the optic.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ VIVITY EXTENDED VISION IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 246 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 21889731
• Report Number: 1119421-2025-01155
• Device Sequence Number: 8115755
• Product Code: POE
• UDI-Device Identifier: 00380652421294
• UDI-Public: (01)00380652421294(17)290120(11)240123(10)15785999
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2025

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: DFT015
• Device Catalogue Number: DFT015.230
• Device Lot Number: 15785999
• 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: 03/26/2025
• Supplement Date Received by Manufacturer: 05/19/2025; 07/03/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 06/12/2025; 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2024
• 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: CLAREON MONARCH IV IOL , INJECTOR; HYDROXYPROPYLMETYLCELLULOZA; MONARCH III IOL , CARTRIDGE D
• Patient Age: 66 YR
• Patient Sex: Male