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

Model Number	DFT015
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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).The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A non-health professional reported that during a cataract surgery with intraocular lens (iol) implant surgery, an iol was damaged by the injector during surgery.Additional information received and stated there was no patient impact to the patient, there was a spare lens to use.The procedure was completed as expected with lens insertion.
Additional Manufacturer Narrative
The lens was returned positioned incorrectly posterior side up in the lens case.Solution was dried on the lens.Both haptics are bent in the gusset and distal area.The optic edge was torn/split/cracked.No associated products returned for evaluation.Complaint history and product history records were reviewed and the documentation indicated the product met release criteria.Associated products were not provided.It is unknown if qualified products were used.The product investigation could not identify a root cause for the reported complaint.The lens was return in the lens case for evaluation.Associated products were not provided.It is unknown if qualified products were used.The use of non-qualified associated products may result in lens delivery issues and/or product damage.The instruction for use (ifu) instructs that an company qualified delivery system and viscoelastic combination should be used.The use of an unqualified combination may cause damage to the lens and potential complications during the implantation process.Alcon recommends using the qualified company iol delivery system or any other company qualified combination.Information was provided in the file that the "iol was damaged by the injector".The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ VIVITY 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: 14065673
• Report Number: 1119421-2022-00704
• Device Sequence Number: 11989535
• Product Code: POE
• UDI-Device Identifier: 00380652421324
• UDI-Public: 00380652421324
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2022

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: 08/09/2025
• Device Model Number: DFT015
• Device Lot Number: 15089085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2022
• Supplement Date Received by Manufacturer: 04/19/2022
• Initial Report FDA Received Date: 04/09/2022
• Supplement Report FDA Received Date: 05/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2020
• 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
• Patient Sex: Unknown