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

Model Number ACU0T0

Device Problem Failure to Eject (4010)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/08/2022

Event Type  malfunction  

Manufacturer Narrative

A sample device was not returned for analysis.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).

Event Description

A nurse reported that during an intraocular lens (iol) implant procedure, plunger went over the iol.The surgery was completed with back up lens during the initial procedure.There was no patient harm.Additional information was requested.

Manufacturer Narrative

Additional information provided in d.9.H.3., h.6.And h.10.The device with the lens was returned loose in a plastic bag.The plunger lock and lens stop have been removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger has advanced to mid-nozzle and has overrode the lens.The lens was located at mid-nozzle.The trailing haptic was folded onto the anterior optic surface along the left side of the plunger.The leading haptic was extended.The nozzle was removed and cleaned for further evaluation.The lens was removed during cleaning.Top coat dye stain testing was conducted with acceptable results.Product history records were reviewed and the documentation indicated the product met release criteria.Viscoelastic was not provided.It is unknown if a qualified product was used.The root cause cannot be determined for the reported complaint.A plunger override was observed.It is unknown if a qualified viscoelastic was used.The instructions 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.Plunger override may occur: ¿ due to rapid advancement faster than the ifu 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 (> 23°c / 73° f) 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.Top coat dye stain testing was conducted with acceptable results.The manufacturer internal reference number is: 2022-28832.

• Brand Name: ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM
• Type of Device: LENS, GUIDE, INTRAOCULAR
• 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: 14713735
• MDR Text Key: 294412214
• Report Number: 1119421-2022-01293
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 00380652395229
• UDI-Public: 00380652395229
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/06/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2024
• Device Model Number: ACU0T0
• Device Lot Number: 15166565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2022
• Initial Date FDA Received: 06/16/2022
• Supplement Dates Manufacturer Received: 09/09/2022
• Supplement Dates FDA Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CENTURION