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

Model Number	SN60WF
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported during the intraocular lens (iol) implantation a scratch was seen on the middle of the iol.Additional information has been requested and received stating the lens was not explanted.
Additional Manufacturer Narrative
A sample device was not returned for analysis.The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A nurse reported during the intraocular lens (iol) implantation a scratch was seen on the middle of the iol.Additional information has been requested and received stating the lens was not explanted.
Additional Manufacturer Narrative
A sample device was not returned for analysis.The complaint history and product history records could not be reviewed because the reporting facility did not provide a lot number or any identification traceable to the manufacturing documentation.The root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
The product was not available to evaluate.Photos of the lens inside the eye were available in the file.Two metal instruments are shown manipulating the lens in the eye.A glare from overhead lights was present in the photo, blocking the most central area of the lens.A red circle on this photo shows an area that has a linear mark.This mark is possibly a scratch.Another view shows a red circle indicating the customer's area of concern.A series of small lines that appear to possibly be scratches are observed.The lens was reported to be an company lens.The lot number information was not provided.A qualified company cartridge and handpiece were used.The viscoelastic information was not provided.Without the viscoelastic information, it is not possible to determine if a qualified product combination was used.The root cause cannot be determined for the reported complaint.The lens was not returned for an evaluation.Based on our observation of the attached photos, the lens was in the eye.The lens may have scratch damage.It is difficult to make a final determination without evaluation of the physical sample.The root cause cannot be determined based on available information.It is not possible to determine if a qualified combination was used.The instruction for use 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.Company recommends using the qualified company iol delivery system or any other company qualified combination.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• 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: 13109761
• Report Number: 1119421-2021-02499
• Device Sequence Number: 1389482
• Product Code: HQL
• UDI-Device Identifier: 00380655095577
• UDI-Public: 00380655095577
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2022

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 Model Number: SN60WF
• Device Catalogue Number: SN60WF.080
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2022
• Supplement Date Received by Manufacturer: 02/16/2022; 02/16/2022
• Initial Report FDA Received Date: 12/29/2021
• Supplement Report FDA Received Date: 02/04/2022; 03/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 INJECTOR; MONARCH III CARTRIDGE D; UNSPECIFIED VISCOELASTIC
• Patient Sex: Unknown