MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number	SN6AT3
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2022
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 ophthalmic surgeon reported that, during intraocular lens (iol) implant procedure, the plunger was firmly attached to the iol.When attempting to retract the plunger, the iol ruptured.Surgery was completed with a replacement lens.There was patient contact involved, however no patient harm and the patient was not hospitalized.Additional information was requested.
Additional Manufacturer Narrative
Additional information provided in d.9., d.10., h.3., h.6., and h.10.Half of the lens was returned inside the qualified company cartridge in a small plastic bag inside the opened lens carton.Inadequate viscoelastic was observed inside the cartridge.An aneurysm has started prior to the fill line and travelled into the thinner tip material along the posterior.The aneurysm enlarged at mid-tip.The tip also has stress lines.The cartridge showed evidence of handpiece use.Based on the presence of the tip aneurysm, this indicates the lens and/or plunger was in an incorrect position at this location during delivery attempt.The lens has been retracted inside the cartridge and was located at the nozzle entry area upon return.Only one half the optic with one haptic was observed inside the cartridge.The lens was rotated completely sideways and the distal haptic tip was broken.No other damage was observed.The remainder of the damaged lens was not returned.Product history records were reviewed and the documentation indicated the product met release criteria.The handpiece information was not provided.A qualified viscoelastic was indicated.The root cause for the reported complaint may be related a failure to follow the instructions for use ifu.An inadequate amount of viscoelastic was observed in the cartridge.The ifu instructs to completely fill the cartridge with ovd (diagram provided) immediately prior to loading and delivery of the lens.Do not attempt to load the lens without adequate ovd in the device.Not adequately filling the device with viscoelastic will result in inadequate coverage of lens and the lens fold path with ovd, which may result in damage.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ TORIC SINGLEPIECE IOL
• Common Device Name: LENS, INTRAOCULAR, TORIC OPTICS
• 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: 15507501
• Report Number: 1119421-2022-02091
• Device Sequence Number: 6090617
• Product Code: MJP
• UDI-Device Identifier: 00380652249959
• UDI-Public: 00380652249959
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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): 10/31/2022

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: 07/25/2026
• Device Model Number: SN6AT3
• Device Catalogue Number: SN6AT3.230
• Device Lot Number: 15241241
• 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: 09/08/2022
• Supplement Date Received by Manufacturer: 10/12/2022
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2021
• 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: MONARCH III IOL CARTRIDGE D; MONARCH IOL , INJECTOR, UNSPECIFIED; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Age: 60 YR
• Patient Sex: Unknown