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	12/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
An other health care professional reported that during intraocular lens (iol) implantation procedure, surgeon noticed a scratched lens.There was patient contact but no patient harm.Additional information was requested, but no further information is available.
Additional Manufacturer Narrative
The lens was returned positioned incorrectly in the lens case inside the lens carton.Viscoelastic was dried on the lens.The optic was semi-folded in the well area of the lens case.Both haptics were tucked into the optic fold.The optic edge was chipped.The lens was cleaned with klrp to further evaluate.After removal of the viscoelastic, the lens relaxed into the original shape.No scratches were observed.The optic posterior surface has a small cracked area.Product history records were reviewed and documentation indicated the product met release criteria.All listed associated products are qualified for use with this lens.No scratches were observed; however, the optic had a cracked area on the posterior.This was most likely interpreted as the reported complaint.The lens was returned in a semi-folded position with both haptics tucked into the optic fold.This would be similar in appearance to a lens inside a cartridge.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met company's release criteria.Based on our observation, it can be reasonably concluded that the damage is not manufacturing related.Due to the presence of surgical solution and the condition of the returned sample, the damage is most likely related to customer handling.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: 18516621
• Report Number: 1119421-2024-00105
• Device Sequence Number: 6732302
• Product Code: HQL
• UDI-Device Identifier: 00380655093245
• UDI-Public: 00380655093245
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/19/2024

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: SN60WF
• Device Catalogue Number: SN60WF.225
• Device Lot Number: 15624952
• 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: 12/22/2023
• Supplement Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2023
• 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: MONARCH II LOADING FORCEPS; MONARCH III CARTRIDGE D; MONARCH III INJECTOR; PROVISC
• Patient Sex: Female