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

Model Number SN60WF

Device Problem Device Damaged by Another Device (2915)

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

Event Type  malfunction  

Manufacturer Narrative

Five samples were returned.Six samples were not returned.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 were six 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 was one case with a method code of testing of actual/suspected device, a results code of no device problem found, and a conclusion code of failure to follow instructions and cause cannot be traced to device.There was one case with a method code of testing of actual/suspected device, a results code of no device problem found, and a conclusion code of failure to follow instructions.The manufacturer internal reference number is: (b)(4).

Event Description

This report summarizes 11 malfunction reports of preloaded intraocular lens (iol) delivery system damaging another device.The reported patient ages range from unknown to 91 years.There were five female patients, one male patient, and five unknown gender.

• 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
• 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 ; 8175514979
• MDR Report Key: 10335155
• MDR Text Key: 202171193
• Report Number: 1119421-2020-01068
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• Number of Events Reported: 11
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/28/2020

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 Model Number: SN60WF
• Device Catalogue Number: SN60WF.XXX
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1