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	Material Discolored (1170)
Health Effect - Clinical Code	Corneal Edema (1791)
Date of Event	03/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare professional reported during intraocular lens (iol) implant procedure, after implant the surgeon noticed that yellow kind of precipitation was there on the central part of optics.Immediately the lens was explanted and replaced with another lens during initial procedure.The procedure was completed on same day without any harm to the patient.Additional information has been received and stated post operative day one microcystic oedema noted, so was given steroidal anti-inflammatory drug eld, moxifloxacin eld, timolol-p, homide eld, and oral steroid.
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).
Additional Manufacturer Narrative
Additional information was provided in d.9., h.3., h.6.And h.11.The lens had been placed into the loading area of the device for return.The lens was removed and evaluated.Viscoelastic was observed on the device.One haptic was broken not returned.The central portion of the anterior surface had three large scrape marks with material removed.This may have been interpreted as the reported complaint.No foreign materiel was observed.A long scrape was also observed on the posterior surface.The optic edge and the haptic on this side were also damaged.This may indicate a plunger override occurred.The lens appeared to be the lens in the photo provided.Product history records were reviewed and the documentation indicated the product met release criteria.Viscoelastic was not provided it is unknown if a qualified viscoelastic was used.The reported foreign material was not observed.The returned lens had extensive damage on the center of the anterior surface.This damage and the removed lens material was most likely interpreted as the reported complaint.The optic edge and haptic were also damaged.This may indicate a plunger override occurred.It is unknown if a qualified viscoelastic was used.The instruction for use (ifu) instructs: during device preparation and implantation of the company 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.The ifu instructs: after the lens has been advanced to 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.Proceeding with implantation of a misfolded trailing haptic or a lens that appears to be ¿out of position¿ can result in a broken haptic or other negative outcome.Plunger override may occur: due to rapid advancement faster than the directions for use (dfu) recommend rate.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 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 allowing the plunger to override the lens.If the device is overfilled with ovd, this can prevent the trailing haptic from being placed properly or move the lens out of position resulting in misfolding.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.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; 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: 19096048
• Report Number: 1119421-2024-00692
• Device Sequence Number: 7812987
• Product Code: HQL
• UDI-Device Identifier: 00380652394772
• UDI-Public: 00380652394772
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/23/2025
• Device Model Number: AU00T0
• Device Lot Number: 15338190
• 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: 03/14/2024
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown