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

Model Number	SN6AT5
Medical Device Problem Codes	Crack (1135); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis.Complaint history and 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 in the reported lot number.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A customer reported, the intraocular lens was scratched during/after insertion.The lens was removed and replaced during the same procedure without report of harm.
Event or Problem Description
Corrected information: the intraocular lens was cracked, after unfolding.
Additional Manufacturer Narrative
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
• MDR Report Key: 11605715
• Report Number: 1119421-2021-00723
• Device Sequence Number: 3521598
• Product Code: MJP
• UDI-Device Identifier: 00380652250993
• UDI-Public: 00380652250993
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

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: 04/30/2024
• Device Model Number: SN6AT5
• Device Catalogue Number: SN6AT5.200
• Device Lot Number: 12713964
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 04/28/2021
• 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 III IOL DELIVERY SYSTEM, CARTRIDGE D
• Patient Age: 71 YR