MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL W/ACRYSERT C DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number	SN6CWS
Medical Device Problem Codes	Device Damaged by Another Device (2915); Material Split, Cut or Torn (4008); Failure to Eject (4010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2022
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.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A government agency reported that during a cataract extraction with intraocular lens (iol) implant procedure, the one haptic of iol was not folded as usual, the iol was rotated as a whole during injecting and the iol was stuck in the tip of the injector.When the iol was pushed in to the patient¿s anterior chamber, the stuck haptic was broken and dissociation, the other haptic was slightly torn with the optic, and the dissociation haptic was removed and the eye was bandaged after applying the miotic medicine.On the second day after the operation, the lens was in place and the slightly torn part was not in optic and the pupil was miosis.The patient had no headache, dizziness, eye pain, nausea and vomiting symptoms.The patient had no discomfort in the follow-up visit one week later.No further information available.
Additional Manufacturer Narrative
A photo as provide which showed a broken haptic on a surface.The company device was not shown.The lens remains implanted.A non-qualified viscoelastic was indicated.Based on the provided photo one haptic was broken.The lens remains implanted.The root cause for the delivery issues may be related to a failure to follow the dfu.A non-qualified viscoelastic was indicted.The dfu (direction for use) instructs: fill the device until viscoelastic can, at a minimum, be observed flowing past the nozzle ¿fill-to¿ line, and into the nozzle tip.This will require approximately 0.2 ml of viscoelastic.Only use an company viscoelastic qualified for use with the company delivery system, that has been allowed to come to the operating room temperature.The use of an unqualified ovd may cause damage to the lens and potential complications during the device preparation and implantation steps.In addition, information was provided that "the iol rotated as a whole during injecting, and the iol was stuck on the tip of injector".This may indicate the lens/plunger was not in an acceptable position for advancement into the eye.The dfu instructs: after the plunger has been advanced to align the front (leading) edge of the optic with the ¿fill-to¿ line, the lens should be visually inspected to determine the position of the haptics.The plunger should be in contact with the trailing optic edge.No part of the lens should exit the nozzle prior to insertion through the incision.After confirming the lens is properly positioned and the haptics are folded properly, proceed with lens implantation by inserting the nozzle tip through the incision.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL W/ACRYSERT C DELIVERY SYSTEM
• Common Device Name: LENS, GUIDE, INTRAOCULAR
• 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: 15028192
• Report Number: 1119421-2022-01552
• Device Sequence Number: 6357612
• Product Code: KYB
• UDI-Device Identifier: 00380652249355
• UDI-Public: 00380652249355
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2022

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 Expiration Date: 08/14/2026
• Device Model Number: SN6CWS
• Device Catalogue Number: SN6CWS.270
• Device Lot Number: 15255443
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 09/17/2022
• Initial Report FDA Received Date: 07/15/2022
• Supplement Report FDA Received Date: 10/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2021
• 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: MEDICAL SODIUM HYALURONATE GEL 0.8ML.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown