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

Model Number	SN6AT5
Medical Device Problem Codes	Device Damaged by Another Device (2915); Failure to Eject (4010)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	07/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A sample device was not returned for analysis.Complaint history and product history records were reviewed and the documentation indicated the product met release criteria.The root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A healthcare professional reported that haptic broke off was noted.Additional information has been received and stated that, during an intraocular lens (iol) implant procedure, iol stuck in the main port when implanted via docking.Therefore iol had to be removed from the port to be loaded and repositioned [implanted] again.However, a piece of the iol broke off when ejecting the iol.Surgeon clarified that it was a piece of the optic, not from the haptic.The backup iol was then quickly implanted after enlarging the main port a bit immediately with full entrance in the eye.The patient did not experience any problems preoperatively and sees fine postoperatively.
Additional Manufacturer Narrative
The lens was returned positioned incorrectly in the lens case.Viscoelastic was dried on the lens.The lens was tilted into the well area of the lens case.One haptic was wrapped around a post of the lens case in the gusset area and bent in the distal area against the inner wall of the lens case.The other haptic was bent in the gusset area against a post.The optic edge was torn against a post of the lens case, and the optic edge was pressed against two separate posts of the lens case.Product history records were reviewed and the documentation indicated the product met release criteria.An unspecified company cartridge and an unspecified company handpiece was used.The 26.5 diopter of the company lens is only qualified for use in the company cartridge with viscoat only.It is unknown if a qualified company cartridge was used.A non-qualified viscoelastic was used.The lens was returned with haptic and optic damage.The root cause may be related to a failure to follow the instruction for use (ifu).A non-qualified viscoelastic was indicated.The ifu instructs: company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The ifu instructs that an company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.Information was also provided that indicated this is not a product issue.Iol stuck in the main port when implanted via docking.It therefore had to be removed from the port to be loaded and repositioned [implanted] again.However, a piece of the iol broke off when ejecting the iol and i didn't think it was expedient to reload it that way (maybe it wouldn't hurt).It was a piece of the optic, not from the haptic.The backup iol was then quickly placed [implanted] after enlarging the main port (considering +26.5d, i should have enlarged the main port a bit immediately) with full entrance in the eye.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: 17440935
• Report Number: 1119421-2023-01366
• Device Sequence Number: 14137065
• Product Code: MJP
• UDI-Device Identifier: 00380652251129
• UDI-Public: 00380652251129
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SN6AT5
• Device Catalogue Number: SN6AT5.265
• Device Lot Number: 15300863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2023
• Supplement Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2021
• 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: HEALON GV.; MONARCH CARTRIDGE.; MONARCH INJECTOR UNSPECIFIED.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR
• Patient Sex: Female