MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF IQ VIVITY TORIC EXTENDED VISION IOL; INTRAOCULAR LENS

Model Number	DFT315
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for analysis.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A facility representative reported with a description of damaged intraocular lens (iol) inside the case.The patient was left aphakic.Additional information has been requested, received and stated the lens was defective with haptics and broken edges inside the case.Secondary iol implantation was done 1 week after the event and there was no patient harm.
Additional Manufacturer Narrative
The lens was returned positioned incorrectly inside the lens case inside the carton.Solution was dried on the lens.One haptic was broken in the gusset area and not returned.The other haptic was broken, sheared off in the distal edge area.The sheared haptic material was returned on the post of the lens case lid.The optic was cut or split from the edge toward the center.An area of the optic was cracked near the center.The optic also has two areas of the edge that are broken.The damaged optic material was returned on the lens.Photos were also provided that matched the returned sample.All product and batch history records are quality reviewed prior to product release.Haptic and optic damage was observed.The product investigation could not identify a root cause for the damage.The observed optic and one haptic damage is similar in appearance to handling related damage.The sheared haptic damage is similar in appearance to lens case related damage.It is unknown if the sheared haptic damage occurred upon replacement into the lens case for returned shipment.The presence of the solution on the returned sample is evidence that the product was subjected to handling.Due to the presence of surgical solution, we are unable to verify that the damage was present when opened.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ VIVITY TORIC EXTENDED VISION 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: 17929042
• Report Number: 1119421-2023-01744
• Device Sequence Number: 6350757
• Product Code: POE
• UDI-Device Identifier: 00380652421782
• UDI-Public: 00380652421782
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P930014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2023

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 Model Number: DFT315
• Device Lot Number: 15368921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 11/12/2023
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female