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

Model Number SN60WF

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/07/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the product was not returned for analysis.The product history and batch records were reviewed and documentation indicated the product met release criteria.The product investigation could not identify a root cause.There have been no other complaints reported in the lot number.The manufacturer internal reference number is: (b)(4).

Event Description

An iol implant card was received with a report of the lens was "removed".The lens was removed and replaced, during the initial procedure, due to the lens was not loaded correctly then damaged upon insertion during an intraocular lens (iol) implant procedure.There was no patient harm.

Manufacturer Narrative

The product was not returned.All product and batch history records are quality reviewed prior to product release.Information was provided that indicated the use of a qualified company cartridge and handpiece.The viscoelastic information was not provided.It is unknown if a qualified viscoelastic was used.The root cause for the event was reported to be due to a loading error by the staff.Based on information provided by the site on the returned questionnaire, the event is unrelated to the product.Follow up information indicated that the lens was removed because it was not loaded correctly then damaged upon insertion.The manufacturer internal reference number is: (b)(4).

• Brand Name: ACRYSOF IQ NATURAL SINGLEPIECE IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): ALCON RESEARCH, LLC - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• MDR Report Key: 10727725
• MDR Text Key: 214544343
• Report Number: 1119421-2020-01536
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 11/24/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.190
• Device Lot Number: 12706381
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/05/2020
• Initial Date FDA Received: 10/23/2020
• Supplement Dates Manufacturer Received: 11/15/2020
• Supplement Dates FDA Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH III D CARTRIDGE; MONARCH III IOL HANDPIECE
• Patient Age: 45 YR