MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM; INTRAOCULAR LENS

Model Number	ACU0T0
Medical Device Problem Codes	Device Damaged by Another Device (2915); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported that during an intraocular lens (iol) implant procedure, iol trailing haptic was broken at the joint after insertion in to the eye and causing the causing scratches and marks on the optic and there was no chance of the lens being able to sit comfortably in the eye without causing further complications.This problem causing delayed surgery time and prolonged anesthetic as the patient was under general anesthetic.Additional information received and stated that, the haptic was broken where it meets the optic and the optic itself was affected.There was no harm caused to the patient as the surgeon was able to cut the lenses inside the eye and replace with a third iol.The only real issue it caused the patient was a prolonged hospital stay due to needing a longer general anesthetic.All issues have been resolved and the patient has good vision following surgery.The patient was not hospitalized and went home the same day.The temperature and humidity levels in theatre were also optimum and caused no problems that may have influenced this event.
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).
Additional Manufacturer Narrative
Only a photo was attached to the file.The photo also appears in the other (b)(4).The file indicated the event occurred two times with two separate lenses and a final third lens was implanted successfully.The photo showed the tip of the company device inside the incision.The leading haptic and the optic appeared to have been completely inserted into the eye.A scratch cannot be confirmed based on this photo.The trailing haptic appeared to be torn at the haptic/optic junction with a portion of the trailing haptic caught inside the device tip.The distal area of the trailing haptic extended outside the device tip and was located inside the eye above or on the anterior surface of the optic.Viscoelastic was not provided.It is unknown if a qualified product was used.The product investigation could not identify a root cause for the reported complaint.The reported scratch could not be confirmed.The available photo shows the trailing haptic caught in the device tip and torn at the optic junction.The plunger position in relation to the broken haptic during advancement cannot be determined.The ifu (instructions for use) 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.It is unknown if a qualified viscoelastic was used.The ifu instructs: during device preparation and implantation of the company iol (intraocular lens) 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 (> 23°c / 73° f) 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.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH 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; 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: 13252721
• Report Number: 1119421-2022-00090
• Device Sequence Number: 4431888
• Product Code: HQL
• UDI-Device Identifier: 00380652395328
• UDI-Public: 00380652395328
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2024
• Device Model Number: ACU0T0
• Device Lot Number: 15244039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/28/2021
• Supplement Date Received by Manufacturer: 02/21/2022
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2021
• 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
• Patient Age: 82 YR
• Patient Sex: Male