MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HUNTINGTON ACRYSOF RESTOR TORIC SINGLEPIECE IOL; LENS, INTRAOCULAR, TORIC OPTICS

Model Number ASKU

Device Problems Break (1069); Crack (1135); Failure to Advance (2524); Defective Device (2588); Device Contamination with Chemical or Other Material (2944); Material Twisted/Bent (2981); Scratched Material (3020); Material Split, Cut or Torn (4008)

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

Event Type  malfunction  

Manufacturer Narrative

There was/were 3 case(s) with a sample received for evaluation, a result code of no device problem found and a conclusion code of no problem detected.There was/were 27 case(s) with no sample received for evaluation, a result code of no findings available and a conclusion code of cause not established.There was/were 3 case(s) with a sample received for evaluation, a result code of no findings available and a conclusion code of cause not established.There was/were 6 case(s) with a sample received for evaluation, a result code of operational problem identified and a conclusion code of cause cannot be traced to device.There was/were 2 case(s) with a sample received for evaluation, a result code of operational problem identified and a conclusion code of cause not established.The manufacturer internal reference number is: 2019-29845.

Event Description

This report summarizes (b)(4) 41 reported events for q1 2019.There was/were 1 female, unknown age, unknown weight patient(s) with reported event(s) of device code crack.There was/were 3 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code crack.There was/were 1 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code device contamination with chemical or other material.There was/were 2 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code failure to advance.There was/were 1 male, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code failure to advance.There was/were 2 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code break.There was/were 1 male, unknown age, unknown weight patient(s) with reported event(s) of device code defective device.There was/were 19 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code defective device.There was/were 2 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code material twisted / bent.There was/were 5 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code scratched material.There was/were 2 female, unknown age, unknown weight patient(s) with reported event(s) of device code scratched material.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code scratched material.There was/were 1 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code material opacification.There was/were 1 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code material split, cut or torn.

• Brand Name: ACRYSOF RESTOR TORIC SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• 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: cindy milam ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152231
• MDR Report Key: 8560405
• MDR Text Key: 147610591
• Report Number: 1119421-2019-00562
• Device Sequence Number: 1
• Product Code: MJP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ASKU
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2019
• 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