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

Model Number ASKU

Device Problems Break (1069); Crack (1135); Defective Component (2292); Inaccurate Delivery (2339); Failure to Advance (2524); Device Contamination with Chemical or Other Material (2944); 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 findings available and a conclusion code of cause not established.There was/were 11 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 1 case(s) with no sample received for evaluation, a result code of results pending completion of investigation and a conclusion code of conclusion not yet available.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 failure to follow instructions.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: (b)(4).

Event Description

This report summarizes e2000003 25 reported events for q4 2018.There was/were 1 male, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code break.There was/were 1 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code break.There was/were 1 female, (b)(6) year old, (b)(6) patient(s) with reported event(s) of device code break.There was/were 1 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 1 male, unknown age, unknown weight patient(s) with reported event(s) of device code inaccurate delivery.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 1 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code defective item.There was/were 1 male, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code defective device.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code defective device.There was/were 1 female, unknown age, unknown weight patient(s) with reported event(s) of device code defective device.There was/were 7 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code defective device.There was/were 5 unknown gender, unknown age, 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 split, cut or torn.There was/were 2 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code crack.

• Brand Name: ACRYSOF RESTOR TORIC SINGLEPIECE IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HUNTINGTON; 6065 kyle lane; huntington WV 25702
• Manufacturer (Section G): ALCON RESEARCH, LTD. - 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: 8283785
• MDR Text Key: 136256061
• Report Number: 1119421-2019-00110
• 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: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• 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: 01/01/2019
• 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