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	02/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the product was not returned for analysis.Product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is:(b)(4).
Event or Problem Description
A facility representative reported via reply card, that during an intraocular lens (iol) implant procedure, the iol was inserted and removed.Additional information was provided by a nurse/coa/director of nursing, that the iol was removed due to a scratch on the optic.The procedure was completed the same day.The cause of the event is unknown.There was no patient harm and the patient's prognosis is good.

• 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
• MDR Report Key: 11685397
• Report Number: 1119421-2021-00840
• Device Sequence Number: 11531318
• Product Code: HQL
• UDI-Device Identifier: 00380652332675
• UDI-Public: 00380652332675
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/19/2021

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 Expiration Date: 11/04/2025
• Device Model Number: SA60WF
• Device Catalogue Number: SA60WF.205
• Device Lot Number: 15113451
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MONARCH II IOL DELIVERY SYSTEM, INJECTOR; MONARCH III IOL DELIVERY SYSTEM, CARTRIDGE C; PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Patient Age: 60 YR