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

Model Number ASKU

Device Problems Bent (1059); Break (1069); Crack (1135); Difficult to Fold, Unfold or Collapse (1254); Hole In Material (1293); Material Opacification (1426); Sticking (1597); Device Damaged Prior to Use (2284); Defective Component (2292); Inaccurate Delivery (2339); Failure to Advance (2524); Wrinkled (2614); Folded (2630); Device Damaged by Another Device (2915); Device Contamination with Chemical or Other Material (2944); Scratched Material (3020); Torn Material (3024)

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

Event Type  malfunction  

Manufacturer Narrative

There was/were 9 case(s) with no sample received for evaluation, a result code of operational problem and a conclusion code of device not returned.There was/were 15 case(s) with a sample received for evaluation, a result code of no failure detected and a conclusion code of no failure detected, device operated within specification.There was/were 1 case(s) with a sample received for evaluation, a result code of incomplete device returned and a conclusion code of cannot complete investigation, incomplete device returned.There was/were 180 case(s) with no sample received for evaluation, a result code of no results available since no evaluation performed and a conclusion code of device not returned.There was/were 1 case(s) with no sample received for evaluation, a result code of operational problem 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 operational context caused or contributed to event.There was/were 101 case(s) with a sample received for evaluation, a result code of operational problem and a conclusion code of operational context caused or contributed to event.There was/were 7 case(s) with no sample received for evaluation, a result code of operational problem and a conclusion code of operational context caused or contributed to event.There was/were 5 case(s) with a sample received for evaluation, a result code of operational problem 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 manufacturing process problem and a conclusion code of manufacturing deficiency.(b)(4).

Event Description

This report summarizes e2000003, 324 reported events for q4 2017.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code break.There was/were 1 unknown gender, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code break.There was/were 1 female, (b)(6) year old, 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 item.There was/were 1 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code device damaged prior to use.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code failure to advance.There was/were 1 female, (b)(6) year old, 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 15 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code foreign material present in device.There was/were 2 unknown gender, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code scratched material.There was/were 3 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code sticking.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code crack.There was/were 1 female, unknown age, unknown weight patient(s) with reported event(s) of device code crack.There was/were 4 female, unknown age, unknown weight patient(s) with reported event(s) of device code defective item.There was/were 3 male, unknown age, unknown weight patient(s) with reported event(s) of device code defective item.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code failure to advance.There was/were 1 female, unknown age, unknown weight patient(s) with reported event(s) of device code failure to advance.There was/were 3 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code folded.There was/were 1 female, unknown age, unknown weight patient(s) with reported event(s) of device code material opacification.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 male, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code torn material.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code crack.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code crack.There was/were 1 female, (b)(6) year old, 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 item.There was/were 1 female, (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 failure to advance.There was/were 1 unknown gender, (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 failure to fold.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 bent.There was/were 1 male, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code break.There was/were 18 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code break.There was/were 11 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code crack.There was/were 1 male, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code device or device component damaged by another device.There was/were 50 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code failure to advance.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 male, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code scratched material.There was/were 78 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code defective item.There was/were 6 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code device or device component damaged by another device.There was/were 1 unknown gender, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code difficult to fold or unfold.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code failure to advance.There was/were 7 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code failure to unfold or unwrap.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 male, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code scratched material.There was/were 1 male, (b)(6) ysear old, 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 sticking.There was/were 2 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code wrinkled.There was/were 1 male, (b)(6)year old, unknown weight patient(s) with reported event(s) of device code break.There was/were 17 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code difficult to fold or unfold.There was/were 1 unknown gender, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code failure to advance.There was/were 9 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code failure to fold.There was/were 4 unknown gender, 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 material opacification.There was/were 1 male, (b)(6) year old, 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 sticking.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code torn material.There was/were 1 female, 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 or device component damaged by another device.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code failure to fold.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code folded.There was/were 1 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code hole in material.There was/were 31 unknown gender, 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 crack.There was/were 1 female, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code crack.There was/were 1 male, unknown age, unknown weight patient(s) with reported event(s) of device code device damaged prior to use.There was/were 1 female, (b)(6) year old, 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, (b)(6) year old, unknown weight patient(s) with reported event(s) of device code failure to advance.There was/were 2 male, unknown age, unknown weight patient(s) with reported event(s) of device code scratched material.There was/were 7 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code torn material.

• Brand Name: ACRYSOF IOL
• Type of Device: INTRAOCULAR LENS
• 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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7230870
• MDR Text Key: 99365421
• Report Number: 1119421-2018-00100
• 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
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• 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: 01/31/2018
• 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
• Patient Outcome(s): Other