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

Model Number	TFNT00
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned.A photo was provided of the lens laying in an opened glove.One haptic appears to be broken in the gusset area.Due to the quality of the photo, the presence of viscoelastic cannot be confirmed.All product and batch history records are quality reviewed prior to product release.Based on our observation of the attached photo, the haptic is broken.The provided photo shows the lens has been removed from the lens case and is laying in an opened glove.The presence of clinical solution on the lens cannot be confirmed.It is difficult to make a determination of handling / damage without evaluation of the physical sample.A final root cause cannot be determined based on available information.There is one other complaint in this lot.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A health care professional reported that, at the time of unpacking the intraocular lens (iol), it was found that haptic was broken.The patient was left aphakic and new iol was implanted after four days.

• Brand Name: ACRYSOF IQ PANOPTIX TRIFOCAL IOL
• Common Device Name: LENS, MULTIFOCAL
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 12330184
• Report Number: 1119421-2021-01574
• Device Sequence Number: 17388716
• Product Code: MFK
• UDI-Device Identifier: 00380652392730
• UDI-Public: 00380652392730
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: P040020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: TFNT00
• Device Catalogue Number: TFNT00.100
• Device Lot Number: 12709981
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 08/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention