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

Model Number	AU00T0
Medical Device Problem Codes	Failure to Fold (1255); Device Difficult to Setup or Prepare (1487); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/25/2025
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 nurse reported during intraocular lens (iol) implant procedure, the lens was loaded as usual according to routine with viscoelastic.The front haptic did not want to fold, and the rear haptic got stuck in the cartridge and broke just as the lens was about to be inserted into the eye.Additional information has been requested and received stating the product came into contact with the eye but was not injected.The procedure was completed, but with a different lens.
Additional Manufacturer Narrative
The device and the lens were returned.The plunger lock and the lens stop were removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was retracted to mid-nozzle.A broken trailing haptic was observed in the device at mid-nozzle.The trailing haptic was broken in the haptic/optic junction.The trailing haptic distal area was misfolded, looped around the plunger tip and extended backward along the right side of the plunger.The remainder of the lens was returned inside a small plastic container.Viscoelastic was dried on the lens.The broken haptic damaged area was observed.The other haptic (leading) was not in a straightened position upon return.The lens was cleaned with klotho-related protein (klrp) to further evaluate.The leading haptic was easily pliable using tweezers to manipulate.The nozzle was removed and cleaned for further evaluation.The broken haptic was removed during cleaning.Topcoat dye stain testing was conducted with acceptable results.A device history record review and a non-conformance review of the reported lot number was conducted.The deviation review did not reveal any potential contributing factors to the reported complaint and all corresponding production release specifications defined in the device master record were met.A non-qualified viscoelastic was used.The root cause for the reported complaint may be related to a failure to follow the instructions for use (ifu).A non-qualified viscoelastic was used.The ifu instructs: during device preparation and implantation of the company intraocular lens (iol) with the company preloaded delivery system, a 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.The ifu instructs: take at least 7 seconds to gently fold the iol by advancing the plunger forward in one smooth, continuous motion until the front edge of the optic is even with the "fill-to" line on the nozzle.Do not allow any portion of the lens to exit the nozzle tip.At this position the blue spring will contact the clear main body.It is important to not advance the plunger abruptly to fold the iol as improper folding and lens damage may occur.The ifu instructs: after the lens has been advanced to the nozzle 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.After confirming the lens is properly positioned and the haptics are folded properly, proceed with lens implantation.Proceeding with implantation of a misfolded haptic or a lens that appears to be "out of position" can result in a broken haptic or other negative outcome, since the haptic may be trapped and stretched, and/or pinched and sheared by the moving plunger.The trailing haptic was observed to be broken in the haptic/optic junction and misfolded, looped across the front of the plunger.The root cause for the misfolded trailing haptic cannot be determined.Haptic folding may be influenced by an intermittent plunger rate or if the operating room temperature is too high (greater than 23 degrees centigrade / 73 degrees fahrenheit).If the operating room temperature is too high, lens folding consistency is negatively affected as the lens more adherent.This may inhibit lens advancement or contribute to incorrect haptic folding.The remainder of the lens was returned outside the device.The leading haptic was not in a straight position upon return.The leading haptic was easily pliable using tweezers.Topcoat dye stain testing of the device was conducted with acceptable results.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 degrees centigrade / 73 degrees 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; 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: 23931447
• Report Number: 1119421-2025-03293
• Device Sequence Number: 17577546
• Product Code: HQL
• UDI-Device Identifier: 00380652394703
• UDI-Public: (01)00380652394703(17)280323(11)250325(10)16017027
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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: 16017027
• 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: 12/08/2025
• Supplement Date Received by Manufacturer: 02/08/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2025
• 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: NUVISC PRO
• Patient Sex: Unknown