MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ PANOPTIX TORIC UV ABSORBING TRIFOCAL IOL; LENS, MULTIFOCAL

Model Number	TFAT30
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: the product was not returned for analysis.Complaint history and product history record could not be reviewed because the reporting facility did not provide a valid lot number or any identification traceable to the manufacturing documentation.Root cause has not been identified.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health care professional reported that during an intraocular lens (iol) implant procedure a crack/scratch was noted on the lens after inserting in the eye.The lens was removed and a new lens was implanted without incident.No patient harm was reported.Additional information has been requested.
Additional Manufacturer Narrative
Product evaluation: the lens was returned positioned incorrectly in the lens case.Blood and solution was dried on the lens.Both haptics are bent in the gusset and distal area.The optic was cut into two portions, typical of insertion and removal.One cut optic portion has a large crack on the posterior side near the central optic zone.Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Information was provided that indicated the use of a qualified cartridge, handpiece and viscoelastic.Root cause: the reported damage was observed.All lenses are 100% inspected for cosmetic attributes and the damage exhibited by the returned complaint sample would not have met release criteria.Based on our observation, and the review of manufacturing records, 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).
Event or Problem Description
A health care professional reported that during an intraocular lens (iol) implant procedure, a crack/scratch was noted on the lens after inserting in the eye.The lens was removed and a new lens was implanted without incident.No patient harm was reported.Additional information has been requested.

• Brand Name: ACRYSOF IQ PANOPTIX TORIC UV ABSORBING TRIFOCAL IOL
• Common Device Name: LENS, MULTIFOCAL
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 11679513
• Report Number: 1119421-2021-00838
• Device Sequence Number: 3495101
• Product Code: MFK
• UDI-Device Identifier: 00380652418775
• UDI-Public: 00380652418775
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2021

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: 04/05/2025
• Device Model Number: TFAT30
• Device Catalogue Number: TFAT30.235
• Device Lot Number: 15062984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 04/16/2021
• Supplement Report FDA Received Date: 05/19/2021
• 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 III CARTRIDGE; MONARCH III CARTRIDGE D; MONARCH III INJECTOR; MONARCH III IOL INJECTOR; PROVISC; PROVISC; MONARCH III CARTRIDGE D; MONARCH III IOL INJECTOR; PROVISC
• Patient Age: 72 YR