MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number	AU00T0
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A health care professional reported that during an intraocular lens (iol) implant procedure, during the preparation doctor found the trailing haptic was broke before implant.Doctor decided to wait for the lens replacement then reschedule for the lens implantation.The surgery was completed on the same day, there was no patient contact and no patient harm.
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).
Additional Manufacturer Narrative
Additional information was provided in d.9., h.3., h.6 and h.11.The device with a broken haptic portion was returned.The plunger lock and lens stop have been removed.The plunger is oriented correctly.Inadequate viscoelastic is observed in the device.No viscoelastic was observed in the nozzle or the tip of the device.The plunger was retracted to mid-nozzle.A broken trailing haptic was observed.The haptic was on the left side of plunger near mid nozzle.The lens was returned outside the device adhered to a piece of plastic.Viscoelastic was dried on the lens.One haptic was broken from the gusset area and was returned still in the device near mid-nozzle.Viscoelastic was not provided.It is unknown if the qualified product was used.The root cause for the reported complaint appears be related to a failure to follow the instructions for use (ifu).No viscoelastic was observed in front of the broken haptic portion in the device.The ifu instructs: fill the device until viscoelastic can be observed flowing to the line on the nozzle tip.This will require approximately 0.2 ml of viscoelastic.If inadequate viscoelastic is placed in the device this will cause inadequate coverage of the lens fold path which may cause the lens to advance incorrectly or become stuck in the device.Only use an company ophthalmic viscoelastic device (ovd) qualified for use with the company pre-loaded delivery system that has been allowed to come to the operating room temperature.The lens was returned outside of device.A broken haptic was returned still in the device.The broken haptic portion is on the left side of the nozzle.The haptic distal tip is oriented toward the nozzle tip.The plunger was retracted.The plunger position in relation to the broken haptic during advancement cannot be determined.The haptic position may indicate the plunger was not fully advanced.If the plunger is not fully advanced the trailing haptic may not release properly from the device.It is unknown if the qualified viscoelastic was used.The ifu instructs: during device preparation and implantation of the company intra ocular lens (iol) with the company preloaded delivery system, an company qualified ophthalmic viscoelastic device (ovd) should be used.The use of an unqualified ovd may cause damage to the lens and potential complications during the device preparation and implantation steps.Broken haptics may occur: due to the use of a non-qualified viscoelastic.The use of an unqualified ovd may cause damage to the lens and potential complications during the device preparation and implantation steps.If the operating room temperature is too high (greater than 23 degree centigrade/ 73 degree fahrenheit) lens folding consistency is negatively affected, the lens is more adherent and this may inhibit lens advancement.In addition, haptic strength (modulus) decreases as the temperature increases and is more likely to break under stress.If a straight trailing haptic occurs and it was not properly detected to be out of position.If the plunger is not fully advanced, or if the plunger is allowed to retract, the trailing haptic may not release properly from the device.Any of the above listed causes alone, or in combination, may create the reported event.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 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: 21046705
• Report Number: 1119421-2024-02666
• Device Sequence Number: 18244973
• Product Code: HQL
• UDI-Device Identifier: 00380652394758
• UDI-Public: (01)00380652394758(17)270217(11)240219(10)15803181
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2025

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: AU00T0
• Device Lot Number: 15803181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2024
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2024
• 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
• Patient Sex: Unknown