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

Model Number ASKU

Device Problems Break (1069); Crack (1135); Material Discolored (1170); Difficult to Fold, Unfold or Collapse (1254); Material Opacification (1426); Failure to Unfold or Unwrap (1669); Inaccurate Delivery (2339); Failure to Advance (2524); Defective Device (2588); Device Damaged by Another Device (2915); Device Contamination with Chemical or Other Material (2944); Material Deformation (2976); 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 12 case(s) with a sample received for evaluation, a result code of operational problem identified and a conclusion code of cause not established.There was/were 3 case(s) with no sample received for evaluation, a result code of operational problem identified and a conclusion code of failure to follow instructions.There was/were 1 case(s) with a sample received for evaluation, a result code of no device problem found and a conclusion code of cause not established.There was/were 105 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 manufacturing process problem identified and a conclusion code of cause traced to manufacturing.There was/were 1 case(s) with a sample received for evaluation, a result code of no device problem found and a conclusion code of failure to follow instructions.There was/were 1 case(s) with a sample received for evaluation, a result code of improper material and a conclusion code of cause cannot be traced to device.There was/were 1 case(s) with a sample received for evaluation, a result code of no findings available and a conclusion code of cause cannot be traced to device.There was/were 1 case(s) with a sample received for evaluation, a result code of improper material and a conclusion code of failure to follow instructions.There was/were 1 case(s) with no sample received for evaluation, a result code of improper material and a conclusion code of failure to follow instructions.There was/were 1 case(s) with no sample received for evaluation, a result code of mutagenic problem and a conclusion code of cause not established.There was/were 49 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 no 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 7 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 1 case(s) with a sample received for evaluation, a result code of operational problem identified and a conclusion code of cause traced to manufacturing.There was/were 7 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 4 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 1 case(s) with a sample received for evaluation, a result code of manufacturing process problem identified and a conclusion code of manufacturing deficiency.There was/were 2 case(s) with a sample received for evaluation, a result code of operational problem identified and a conclusion code of unintended use error caused or contributed to event.The manufacturer internal reference number is: 2019-53473.

Event Description

This report summarizes 205 events for q2 2019.There was/were 1 male, (b)(6), 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 item.There was/were 1 female, (b)(6), unknown weight patient(s) with reported event(s) of device code defective item.There was/were 2 female, (b)(6), unknown weight patient(s) with reported event(s) of device code defective device.There was/were 66 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code defective device.There was/were 2 male, 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 defective item.There was/were 5 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code material split, cut or torn.There was/were 1 female, unknown age, unknown weight patient(s) with reported event(s) of device code material split, cut or torn.There was/were 1 female, 71 year old, unknown weight patient(s) with reported event(s) of device code material split, cut or torn.There was/were 1 male, (b)(6), unknown weight patient(s) with reported event(s) of device code scratched material.There was/were 1 male, (b)(6), unknown weight patient(s) with reported event(s) of device code scratched material.There was/were 5 male, unknown age, unknown weight patient(s) with reported event(s) of device code scratched material.There was/were 1 male, (b)(6), unknown weight patient(s) with reported event(s) of device code scratched material.There was/were 1 male, 76 year old, 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), unknown weight patient(s) with reported event(s) of device code scratched material.There was/were 32 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code scratched material.There was/were 1 female, unknown age, unknown weight patient(s) with reported event(s) of device code crack.There was/were 2 male, unknown age, unknown weight patient(s) with reported event(s) of device code crack.There was/were 1 male, (b)(6), unknown weight patient(s) with reported event(s) of device code crack.There was/were 6 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code crack.There was/were 9 unknown gender, unknown age, 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 failure to advance.There was/were 1 female, (b)(6), 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 material deformation.There was/were 1 male, unknown age, unknown weight patient(s) with reported event(s) of device code material deformation.There was/were 3 female, unknown age, unknown weight patient(s) with reported event(s) of device code break.There was/were 22 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code break.There was/were 2 male, unknown age, unknown weight patient(s) with reported event(s) of device code break.There was/were 1 female, unknown age, unknown weight patient(s) with reported event(s) of device code device contamination with chemical or other material.There was/were 10 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 4 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code material twisted / bent.There was/were 1 female, (b)(6), unknown weight patient(s) with reported event(s) of device code inaccurate delivery.There was/were 2 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code inaccurate delivery.There was/were 2 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code material opacification.There was/were 4 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code difficult to fold or unfold.There was/were 1 female, (b)(6), unknown weight patient(s) with reported event(s) of device code failure to unfold or unwrap.There was/were 1 female, unknown age, unknown weight patient(s) with reported event(s) of device code failure to unfold or unwrap.There was/were 2 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code failure to unfold or unwrap.There was/were 1 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code material discolored.There was/were 1 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code device or device component damaged by another device.

• Brand Name: ACRYSOF 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: cindy milam ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152231
• MDR Report Key: 8841909
• MDR Text Key: 153102279
• Report Number: 1119421-2019-01212
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930014
• 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: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• 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: 07/01/2019
• 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