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

Model Number	ACU0T0
Medical Device Problem Codes	Failure to Deliver (2338); Difficult to Advance (2920); Failure to Eject (4010); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2021
Type of Reportable Event	Malfunction
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.Additional information was requested and received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A safety manager reported that during an intraocular lens (iol) implant procedure the lens delivery failed.The surgeon noticed the resistance in the injector, the injector arm did not engage the lens and passed over the iol.There was a patient contact with no patient harm.Additional information was requested and received.
Additional Manufacturer Narrative
Correction: on initial mdr the fda product problem of 2338 was an error.It should have been 4010 on the original mdr ¿ (corrected information provided in h.10.) additional information reported in h.3., h.6.And h.10.A non-qualified viscoelastic was indicated.The root cause may be related to a failure to follow the ifu.A non-qualified viscoelastic was used in the device.Material properties of non-qualified ovds may contribute to underfill, overfill, misfolding of the haptics, or other inconsistent folding outcomes.As stated in the ifu, only qualified company viscoelastics must be used in conjunction with the device.All other viscoelastics are not qualified for use.Lens delivery performance may be negatively affected when using other non-qualified viscoelastics leading to lens delivery issues and /or damage.The use of non-qualified viscoelastics is considered a failure to follow the ifu and is not recommended under any circumstance.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ ASPHERIC UV ABSORBING IOLWITH ULTRASERT DELIVERY SYSTEM
• Common Device Name: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 12108885
• Report Number: 1119421-2021-01306
• Device Sequence Number: 14378835
• Product Code: KYB
• UDI-Device Identifier: 00380652395366
• UDI-Public: 00380652395366
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2021

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: 10/09/2023
• Device Model Number: ACU0T0
• Device Lot Number: 15105443
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/11/2021
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 08/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HYALIN PLUS VISCOELASTIC; HYALIN PLUS VISCOELASTIC