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	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product 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.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported that during cataract surgery with intraocular lens (iol) implantation, the trailing haptic was chipped off by the plunger, despite being completely filled with ophthalmic viscosurgical device (ovd).The surgery was successfully completed because the damaged iol implanted inside the bag.They planned to schedule another surgery to replace the damaged iol.Additional information was received stating that, the patient was stable and there was no patient harm.
Additional Manufacturer Narrative
Corrected information was provided in d.4.Additional information was provided in b.5.,d.10., h.3., h.6.And h.11.The device with the broken haptic was returned in the blister tray in the carton.The plunger lock and the lens stop were removed.The plunger was oriented correctly.Viscoelastic was observed in the device.The plunger was retracted to mid-nozzle.A broken haptic was observed.The haptic was on the left side of the plunger in the groove (correct).The haptic distal tip was oriented toward the nozzle tip.The remainder of the lens was not returned.Product history records were reviewed, and the documentation indicated the product met release criteria.A qualified viscoelastic was used.The root cause for the reported complaint could not be determined.The broken haptic was on the correct side of the plunger.The distal portion was facing the end of the nozzle.The plunger was retracted.The plunger position in relation to the broken haptic during advancement cannot be determined.The haptic position may indicate the plunger was not fully advanced.If the plunger is not fully advanced the trailing haptic may not release properly from the device.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 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.Information was provided that the damaged lens was left implanted.The follow up information indicated that they will schedule an explant and replace the damaged lens with a replacement lens.The specific model and diopter of the replacement lens was not provided.New information was received.According to the doctor, a replacement lens was already used.The condition of the patient is good.The replacement lens information was not provided.File will be reopened if new information or the remainder of the lens is received.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information was received stating that the lens was exchanged with an unspecified iol in a secondary procedure.The patient¿s condition was good.

• 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: 19919215
• Report Number: 1119421-2024-01524
• Device Sequence Number: 12806404
• Product Code: HQL
• UDI-Device Identifier: 00380652394901
• UDI-Public: (01)00380652394901(17)261101(11)231103(10)15743809
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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 Model Number: AU00T0
• Device Lot Number: 15743809
• 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: 07/09/2024
• Supplement Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2023
• 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: REPLACEMENT LENS: UNSPECIFIED IOL; VISCOAT OPHTHALMIC VISCOSURGICAL DEVICE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown