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

Model Number SN60WF

Device Problem Particulates (1451)

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

Event Date 04/13/2021

Event Type  malfunction  

Manufacturer Narrative

Complaint history and product history records were reviewed and documentation indicated the product met release criteria.Root cause has not been identified.There were no other complaints reported in the lot number.Additional information was requested.The manufacturer internal reference number is:(b)(4).

Event Description

A customer reported that during implantation of an intraocular lens (iol) a small metallic fragment on the anterior surface of one of the lens was noted.The foreign body was removed during the same procedure and the surgery was completed the same day.Additional information was requested.

Manufacturer Narrative

Additional information provided in d.9, h.3, h.6 and h.10 the product was not returned.The lens remains implanted.A photo was provided of a small dark speck on a sponge tip.No determination as to the nature of the particle can be determined from the photo.The sponge tip was returned in a specimen cup.The sample was sent to the lab unopened.The swab was visually and microscopically examined and no obvious particles were observed.The swab, container and interior of the cap were thoroughly examined by two different lab analyst and no particles were observed.Qualified associated products were indicated.The root cause could not be determined.The lens remains implanted.Lab analysis of the returned container and swab could not find the small particle observed in the provided photo.No determination can be made as to the nature and origin the small speck observed in the photo.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: 11805405
• MDR Text Key: 249956809
• Report Number: 1119421-2021-00996
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 00380655095744
• UDI-Public: 00380655095744
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SN60WF
• Device Catalogue Number: SN60WF.270
• Device Lot Number: 15020037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Date Manufacturer Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MONARCH III IOL CARTRIDGE D; MONARCH III IOL INJECTOR; PROVISC; MONARCH III IOL CARTRIDGE D; MONARCH III IOL INJECTOR; PROVISC
• Patient Age: 55 YR