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

Model Number	SN6AT5
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
An ophthalmic surgeon reported that during a cataract extraction with intraocular lens (iol) implant procedure, a slightly off-center crack on iol won't have too many consequences found after iol injection.The implant was perfectly normal before going into the injector.The zonula was very fragile, hence did not want to take the risk of removing the iol and putting another one.The surgeon tried to rub the back side of the implant, hoping that it was just dust stuck to the implant, but without success.Additional information was received stating the patient was seen only one day after surgery for the moment, but the visual acuity of the patient at one day after surgery was rather reassuring at 6/10 without correction even if the fissure was visible, a little off center.
Additional Manufacturer Narrative
The product was not returned for analysis; the lens remains implanted.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 for this lot.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was not returned.Photos were provided of a toric single piece lens in the eye.A mark or material was observed just off center on the right side.Unable to determine the nature or origin of mark.A qualified cartridge was indicated with an unspecified monarch handpiece.The viscoelastic was not provided it is unknown if a qualified product was used.A root cause could not be determined for the reported damage.The lens remains implanted and no issues have been reported.It could not be determined from the provided photos if the pictured area was a crack.Per the instruction for use (ifu): company foldable iols are qualified for use with an company qualified delivery system (handpiece and cartridge) and ophthalmic viscosurgical device (ovd) combination.The use of an unqualified combination may cause damage to the iol and potential complications during the implantation process.The ifu also instructs to completely fill the cartridge with ovd 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: 15697087
• Report Number: 1119421-2022-02299
• Device Sequence Number: 15299822
• Product Code: MJP
• UDI-Device Identifier: 00380652251044
• UDI-Public: 00380652251044
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2023

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: SN6AT5
• Device Catalogue Number: SN6AT5.225
• Device Lot Number: 15335069
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2022
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 10/29/2022
• Supplement Report FDA Received Date: 01/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2022
• 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 CARTRIDGE D; MONARCH INJECTOR, UNSPECIFIED
• Patient Age: 84 YR
• Patient Sex: Female