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	Break (1069); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
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 non-health care professional reported with the description, there was a faulty lens which was unable to load correctly and the haptic was broken.There was no harm and no contact with the patient.Additional information was received and stated, event occurred during loading and the surgery was able to complete with the another lens.
Additional Manufacturer Narrative
Additional information was provided in d.3.,d.10.,h.3.,h.6 and h.11.A photo was provided.A partial side view of a used ultrasert device was shown.The lens was placed posterior surface up on the exterior of the device on the side of the device prior to the loading area.There appears to be viscoelastic dried on the lens optic.One haptic was broken in the gusset area.The broken haptic portion was not visible in this photo.No other photos provided.A non-qualified viscoelastic was indicated.Based on our observation of the photo, the haptic is broken and clinical solution appears to be present on the lens.The product has not been received to evaluate.It is difficult to make a final determination without evaluation of the physical sample.The root cause may be related to a failure to follow the instruction for use (ifu).A non-qualified viscoelastic was used in the device.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.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.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 the device is overfilled with ovd as this can prevent the trailing haptic from being placed properly or move the lens out of position resulting in misfolding.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.File will be reopened when new information or the product 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 device and the lens were returned in the blister tray inside the carton.The lens stop and plunger lock were removed.The plunger was oriented correctly.Inadequate viscoelastic was observed in the device.The plunger was retracted to mid-nozzle.A broken haptic was observed.The haptic was on the left side of the plunger in the groove (correct).The distal portion was facing the end of the nozzle.The lens was returned adhered in viscoelastic to the exterior barrel of the device.One haptic was broken in the gusset area and returned still inside the device.A photo was provided that shows the damaged lens on the exterior of the device.Product history records were reviewed and the documentation indicated the product met release criteria.A non-qualified viscoelastic was used.A broken haptic was observed inside the device which was most likely interpreted as part of the complaint description faulty lens.The root cause for the reported complaint is most likely 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 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 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 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: 21181328
• Report Number: 1119421-2025-00195
• Device Sequence Number: 20969032
• Product Code: HQL
• UDI-Device Identifier: 00380652394765
• UDI-Public: (01)00380652394765(17)270317(11)240318(10)15813933
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2025

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: Lay User/Patient
• Device Model Number: AU00T0
• Device Lot Number: 15813933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2024
• Supplement Date Received by Manufacturer: 02/26/2025; 06/03/2025
• Initial Report FDA Received Date: 01/17/2025
• Supplement Report FDA Received Date: 03/25/2025; 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2024
• 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: NUVISC PRO.
• Patient Sex: Unknown