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

Model Number SN60WF

Device Problems Device Damaged by Another Device (2915); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Four samples were returned.Twenty samples were not returned.There were 19 cases with a method code of device not returned, a results code of no findings available, and a conclusion code of cause not established.There was one case with a method code of testing of actual/suspected device, a results code of operational problem identified, and a conclusion code of cause not established.There were two cases with a method code of testing of actual/suspected device, a results code of operational problem identified, and a conclusion code of cause cannot be traced to device.There was one case with a method code of device not returned, a results code of operational problem identified, and a conclusion code of cause not established.(b)(4).

Event Description

This report summarizes 24 malfunction reports of preloaded intraocular lens (iol) delivery system damaging another device.The reported patient ages are unknown.There were six male patients, and 18 unknown gender.

Manufacturer Narrative

Additional information provided in h.10.One file received additional information making it no longer reportable and will be removed from the summary of this report.No additional information will be submitted for this single file.The manufacturer internal reference number is: (b)(4).

Event Description

This report summarizes 22 malfunction reports of defective intraocular lenses (iols).

Manufacturer Narrative

One file received additional information making it no longer reportable and will be removed from the summary of this report.No additional information will be submitted for this single file.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: 10335162
• MDR Text Key: 201875859
• Report Number: 1119421-2020-01067
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• PMA/PMN Number: P930014
• Number of Events Reported: 24
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/28/2021

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 Model Number: SN60WF
• Device Catalogue Number: SN60WF.XXX
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/28/2020
• Supplement Dates Manufacturer Received: 10/01/2020; 01/01/2021
• Supplement Dates FDA Received: 10/28/2020; 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1