MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF ASPHERIC UV ABSORBING SINGLEPIECE IOL; INTRAOCULAR LENS

Model Number	SA60WF
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Only the empty lens carton was returned with the packaging inserts.The lens, lens case, and peel pouch were not returned for evaluation.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.The file indicated the use of a qualified associated cartridge.The handpiece and viscoelastic were not provided.It is unknown if qualified products were used.The root cause could not be determined for the reported complaint.The iol was not returned for an evaluation.There are no other complaints in this lot.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non health care professional reported that during an intraocular lens (iol) implant procedure, the surgeon noticed a scratch on the iol.The lens removed from the eye during initial procedure.No patient injury reported.Additional information has been requested.

• Brand Name: ACRYSOF ASPHERIC UV ABSORBING 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: 15867992
• Report Number: 1119421-2022-02493
• Device Sequence Number: 14754967
• Product Code: HQL
• UDI-Device Identifier: 00380652332620
• UDI-Public: 00380652332620
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/28/2022

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: SA60WF
• Device Catalogue Number: SA60WF.180
• Device Lot Number: 15344093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2022
• Initial Report FDA Received Date: 11/28/2022
• Date Device Manufactured: 02/07/2022
• 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
• Patient Sex: Unknown