MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ PANOPTIX TRIFOCAL IOL; LENS, MULTIFOCAL

Model Number	TFNT00
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/15/2024
Type of Reportable Event	Serious Injury
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
A facility representative reported that during an intraocular lens (iol) implant procedure, it was noted that the lens broken upon ejection from injector.The iol was explanted during initial procedure.Operation rescheduled and another new unspecified iol was implanted one week later.No patient harm reported.Additional information has been requested.
Additional Manufacturer Narrative
Correction information provided in d.4.Additional information provided in d.9., h.3., h.6.And h.11.The lens was returned wrapped in white gauze material placed into a small biohazard bag inside the lens carton.Both haptic distal tips were broken and not returned.The optic was broken into three portions.All three portions were returned.The largest optic portion, containing one haptic, had two linear scratches along the anterior surface between the center and the optic edge.The second larger optic portion, containing the other haptic, has a large gouge mark on the posterior surface in the central optic ring area.The optic material from this gouge was lifted and still present.Another very small gouge was observed on the optic posterior nearer to the optic edge.The posterior optic was cracked from the edge and extended toward the gouge mark.The anterior optic has a large area of scuff marks near the edge and was cracked from the optic edge, extending toward the optic center.The smallest broken optic portion was returned with scratch marks on the anterior surface.Product history records were reviewed and the documentation indicated the product met release criteria.A qualified cartridge, handpiece, and viscoelastic were used.The reported damage was observed.All lenses are 100 percent inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met company release criteria.Based on our observation, and the review of manufacturing records, it can be reasonably concluded that the damage is not manufacturing related.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely related to customer handling.The instructions for use (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 ophthalmic viscosurgical device (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.The company 22.0 diopter (add power +2.2/+3.2 diopter) lens was removed and replaced.The replacement lens information was not provided.File will be reopened if new information is received.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ PANOPTIX TRIFOCAL IOL
• Common Device Name: LENS, MULTIFOCAL
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 20266861
• Report Number: 1119421-2024-01870
• Device Sequence Number: 14301112
• Product Code: MFK
• UDI-Device Identifier: 00380652357777
• UDI-Public: (01)00380652357777(17)280414(11)230417(10)15637156(21)15637156050
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.220
• Device Lot Number: 15637156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 12/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2023
• 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: DISCOVISC.; MONARCH III CARTRIDGE D.; MONARCH III INJECTOR.; REPLACEMENT: UNSPECIFIED LENS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male