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); Use of Device Problem (1670); Defective Component (2292); Inaccurate Delivery (2339); Failure to Advance (2524); Dent in Material (2526); Split (2537); Folded (2630); Device Contamination with Chemical or Other Material (2944); Scratched Material (3020); Torn Material (3024)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

There was/were 1 case(s) with a 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 4 case(s) with a sample received for evaluation, a result code of no results available since no evaluation performed and a conclusion code of cannot complete investigation, incomplete device returned.There was/were 245 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 2 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 1 case(s) with a sample received for evaluation, a result code of contamination by foreign material and a conclusion code of device received in condition making evaluation impossible.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 8 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 7 case(s) with no sample received for evaluation, a result code of improper material and a conclusion code of device not returned.There was/were 6 case(s) with a sample received for evaluation, a result code of manufacturing process problem and a conclusion code of manufacturing deficiency.There was/were 118 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 1 case(s) with a sample received for evaluation, a result code of no results available since no evaluation performed and a conclusion code of device received in condition making evaluation impossible.There was/were 1 case(s) with a sample received for evaluation, a result code of packaging compromised and a conclusion code of manufacturing deficiency.The manufacturer internal reference number is: (b)(4).

Event Description

This report summarizes e2000003 399 reported events for q1 2018.There was/were (b)(6) unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code bent.There was/were (b)(6) male, unknown age, unknown weight patient(s) with reported event(s) of device code break.There was/were 1 female, (b)(6), unknown weight patient(s) with reported event(s) of device code defective item.There was/were 1 male, (b)(6), unknown weight patient(s) with reported event(s) of device code defective item.There was/were 1 male, (b)(6), 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), 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 1 male, (b)(6), unknown weight patient(s) with reported event(s) of device code failure to advance.There was/were 5 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code material opacification.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 1 unknown gender, (b)(6), unknown weight patient(s) with reported event(s) of device code scratched material.There was/were 2 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code sticking.There was/were 1 male, unknown age, unknown weight patient(s) with reported event(s) of device code use of device issue.There was/were 1 female, (b)(6), 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 dent in material.There was/were 1 male, (b)(6), unknown weight patient(s) with reported event(s) of device code device or device component damaged by another device.There was/were 21 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code difficult to fold or unfold.There was/were 4 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), unknown weight patient(s) with reported event(s) of device code inaccurate delivery.There was/were 3 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code material deformation.There was/were 1 male, (b)(6), 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 bent.There was/were 3 female, unknown age, unknown weight patient(s) with reported event(s) of device code break.There was/were 1 female, (b)(6), unknown weight patient(s) with reported event(s) of device code crack.There was/were 1 female, (b)(6), 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 1 female, (b)(6), 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 1 female, (b)(6), 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 1 male, (b)(6), unknown weight patient(s) with reported event(s) of device code failure to advance.There was/were 1 male, (b)(6), unknown weight patient(s) with reported event(s) of device code failure to advance.There was/were 2 female, 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 device or device component damaged by another device.There was/were 1 male, (b)(6), unknown weight patient(s) with reported event(s) of device code failure to advance.There was/were 1 male, (b)(6), unknown weight patient(s) with reported event(s) of device code failure to advance.There was/were (b)(6) 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), unknown weight patient(s) with reported event(s) of device code material opacification.There was/were 1 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 break.There was/were (b)(6) unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code failure to unfold or unwrap.There was/were 19 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code foreign material present in device.There was/were 1 male, (b)(6), unknown weight patient(s) with reported event(s) of device code scratched material.There was/were 55 unknown gender, 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 use of device issue.There was/were 1 male, (b)(6), 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 1 female, (b)(6), unknown weight patient(s) with reported event(s) of device code crack.There was/were 15 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code crack.There was/were 2 male, (b)(6), unknown weight patient(s) with reported event(s) of device code defective item.There was/were 86 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code defective item.There was/were 1 female, unknown age, unknown weight patient(s) with reported event(s) of device code difficult to fold or unfold.There was/were 3 male, unknown age, unknown weight patient(s) with reported event(s) of device code difficult to fold or unfold.There was/were 6 female, 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 unfold or unwrap.There was/were 6 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 sticking.There was/were 1 male, (b)(6), unknown weight patient(s) with reported event(s) of device code sticking.There was/were 9 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code torn material.There was/were 1 male, (b)(6), unknown weight patient(s) with reported event(s) of device code use of device issue.There was/were 1 female, (b)(6), unknown weight patient(s) with reported event(s) of device code break.There was/were 1 female, (b)(6), unknown weight patient(s) with reported event(s) of device code crack.There was/were 1 female, (b)(6), unknown weight patient(s) with reported event(s) of device code defective item.There was/were 13 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code failure to fold.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 male, (b)(6), unknown weight patient(s) with reported event(s) of device code foreign material present in device.There was/were 2 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code inaccurate delivery.There was/were 1 female, (b)(6), 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 male, (b)(6), 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 wrinkled.There was/were 1 male, (b)(6), unknown weight patient(s) with reported event(s) of device code defective item.There was/were 1 male, 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 difficult to fold or unfold.There was/were 1 male, (b)(6), 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 unfold or unwrap.There was/were 2 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code hole in material.There was/were 2 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code split.There was/were 1 female, (b)(6), unknown weight patient(s) with reported event(s) of device code bent.

• 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: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7466099
• MDR Text Key: 107205814
• Report Number: 1119421-2018-00475
• 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: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• 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: 01/01/2018
• 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