MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM; LENS, GUIDE, INTRAOCULAR

Model Number	AU00T0
Medical Device Problem Codes	Optical Decentration (1360); Device Damaged by Another Device (2915); Failure to Eject (4010)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/14/2022
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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported during a cataract extraction with an intraocular lens implant procedure, difficulty encountered during injection.The surgeon moved the plunger up a little to reinject correctly, at which point the proximal haptic was found to be missing, torn at the base of the junction with the optic.The surgeon decided to leave the implant in the capsular bag and to finish the surgery normally with the addition of miostat at the very end of the surgery to contract the iris and maintain the implant in the bag.Additional information has been requested.
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information has been requested and received which state the lens remained inside the eye and it was decentered.
Additional Manufacturer Narrative
The delivery system was not returned for evaluation.A photo was provided of a haptic, broken gusset area on a blue drape.Viscoelastic could not be confirmed on the haptic due to the texture of the drape.No determination as to cause can be made from the photo.Product history records were reviewed and documentation indicated the product met release criteria.A qualified viscoelastic was indicated.The plunger position in relation to the broken haptic during advancement cannot be determined.The ifu 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.Gently advance the plunger in one smooth, continuous motion.Do not advance the plunger too fast or lens damage may occur.Information was provided that the surgeon ¿moved the plunger up a little to reinject correctly¿, at which point the proximal haptic was found to be missing, torn at the base of the junction with the optic.Th specific issue which necessitated the plunger ¿adjustment¿ was not provided.Broken haptics may occur: ¿ 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 SINGLEPIECE IOL WITH ULTRASERT DELIVERY SYSTEM
• Common Device Name: 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: 13732977
• Report Number: 1119421-2022-00448
• Device Sequence Number: 5063051
• Product Code: KYB
• UDI-Device Identifier: 00380652394673
• UDI-Public: 00380652394673
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2024
• Device Model Number: AU00T0
• Device Lot Number: 15260506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/15/2022
• Supplement Date Received by Manufacturer: 03/14/2022; 05/11/2022
• Initial Report FDA Received Date: 03/11/2022
• Supplement Report FDA Received Date: 04/06/2022; 06/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MIOSTAT SOLUTION; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Age: 74 YR
• Patient Sex: Female