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

Model Number ASKU

Device Problems Bent (1059); Break (1069); Crack (1135); Material Discolored (1170); Difficult to Fold, Unfold or Collapse (1254); Failure to Fold (1255); Hole In Material (1293); Material Opacification (1426); Material Too Rigid or Stiff (1544); Failure to Unfold or Unwrap (1669); Defective Component (2292); Inaccurate Delivery (2339); Failure to Advance (2524); Dent in Material (2526); Wrinkled (2614); Folded (2630); Device Contamination with Chemical or Other Material (2944); Material Distortion (2977); Material Twisted/Bent (2981); Scratched Material (3020); Torn Material (3024)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

This report summarizes (b)(4) 396 reported events for q2 2017.There was/were 2 reported event(s) of device code bent.There was/were 32 reported event(s) of device code break.There was/were 15 reported event(s) of device code crack.There was/were 97 reported event(s) of device code defective item.There was/were 2 reported event(s) of device code dent in material.There was/were 11 reported event(s) of device code device damaged prior to use.There was/were 11 reported event(s) of device code device or device component damaged by another device.There was/were 26 reported event(s) of device code difficult to fold or unfold.There was/were 57 reported event(s) of device code failure to advance.There was/were 25 reported event(s) of device code failure to fold.There was/were 10 reported event(s) of device code failure to unfold or unwrap.There was/were 6 reported event(s) of device code folded.There was/were 22 reported event(s) of device code foreign material present in device.There was/were 1 reported event(s) of device code hole in material.There was/were 7 reported event(s) of device code inaccurate delivery.There was/were 2 reported event(s) of device code material discolored.There was/were 1 reported event(s) of device code material distortion.There was/were 3 reported event(s) of device code material opacification.There was/were 1 reported event(s) of device code material rigid or stiff.There was/were 2 reported event(s) of device code material twisted.There was/were 68 reported event(s) of device code scratched material.There was/were 7 reported event(s) of device code torn material.There was/were 3 reported event(s) of device code use of device issue.There was/were 5 reported event(s) of device code wrinkled.

Manufacturer Narrative

Corrected information, as follows: there was/were 1 case(s) with a sample received for evaluation, a result code of operational problem and a conclusion code of device received in condition making evaluation impossible.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 2 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 6 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 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 a sample received for evaluation, a result code of improper physical structure and a conclusion code of operational context caused or contributed to event.There was/were 166 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 no sample received for evaluation, a result code of no results available since no evaluation performed and a conclusion code of use error caused or contributed to event.There was/were 16 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 not returned.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 no results available since no evaluation performed and a conclusion code of cannot complete investigation, incomplete device returned.There was/were 176 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 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 3 case(s) with a sample received for evaluation, a result code of operational problem and a conclusion code of device not returned.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 failure to follow instructions.There was/were 18 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 1 case(s) with a sample received for evaluation, a result code of improper physical structure and a conclusion code of manufacturing deficiency.There was/were 1 case(s) with a sample received for evaluation, a result code of no failure detected and a conclusion code of no failure detected, device out of specification.There was/were 5 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 1 case(s) with a sample received for evaluation, a result code of packaging problem and a conclusion code of manufacturing deficiency.There was/were 2 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.The manufacturer internal reference number is: (b)(4).

Event Description

This report summarizes e2000003 392 reported events for q3 2017.There was/were 2 male, unknown age, unknown weight patient(s) with reported event(s) of device code break.There was/were 1 male, (b)(6), unknown weight patient(s) with reported event(s) of device code defective item.There was/were 10 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 male, (b)(6).Patient(s) with reported event(s) of device code failure to advance.There was/were 1 male, 69 year old, 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 female, (b)(6), 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 foreign material present in device.There was/were 18 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code foreign material present in device.There was/were 7 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 distortion.There was/were 1 female, (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 1 male, unknown age, 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 wrinkled.There was/were 4 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code wrinkled.There was/were 3 male, unknown age, unknown weight patient(s) with reported event(s) of device code defective item.There was/were 1 unknown, unknown age, 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 female, (b)(6), unknown weight patient(s) with reported event(s) of device code device damaged prior to use.There was/were 8 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 female, (b)(6), unknown weight patient(s) with reported event(s) of device code difficult to fold or unfold.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), unknown weight patient(s) with reported event(s) of device code hole in material.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), 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 1 unknown, 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 defective item.There was/were 7 female, unknown age, 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 72 unknown gender, 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 female, (b)(6), 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 8 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, unknown age, unknown weight patient(s) with reported event(s) of device code material twisted.There was/were 1 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code material twisted.There was/were 1 female, (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 torn material.There was/were 1 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code bent.There was/were 12 unknown gender, unknown age, 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 male, (b)(6), 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 folded.There was/were 1 female, (b)(6), 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 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 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 device or device component damaged by another device.There was/were 2 female, unknown age, unknown weight patient(s) with reported event(s) of device code failure to advance.There was/were 22 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code failure to fold.There was/were 1 male, (b)(6), 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 material rigid or stiff.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, (b)(6), unknown weight patient(s) with reported event(s) of device code torn material.There was/were 26 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code break.There was/were 2 female, unknown age, 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 male, (b)(6), unknown weight patient(s) with reported event(s) of device code difficult to fold or unfold.There was/were 2 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code material opacification.There was/were 1 female, (b)(6), unknown weight patient(s) with reported event(s) of device code scratched material.There was/were 1 female, (b)(6).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 female, 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 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 2 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code material discolored.There was/were 1 female, (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 use of device issue.There was/were 1 male, (b)(6), unknown weight patient(s) with reported event(s) of device code bent.There was/were 1 female, (b)(6), unknown weight patient(s) with reported event(s) of device code break.There was/were 2 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 defective item.There was/were 1 male, (b)(6).Patient(s) with reported event(s) of device code defective item.There was/were 1 male, unknown age, (b)(6).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 dent in material.There was/were 1 male, (b)(6).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), unknown weight patient(s) with reported event(s) of device code difficult to fold or unfold.There was/were 22 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), 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 failure to fold.There was/were 1 male, (b)(6), unknown weight patient(s) with reported event(s) of device code scratched material.There was/were 2 male, unknown age, unknown weight patient(s) with reported event(s) of device code scratched material.There was/were 53 unknown gender, unknown age, unknown weight patient(s) with reported event(s) of device code scratched material.There was/were 5 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: 6754930
• MDR Text Key: 81591559
• Report Number: 1119421-2017-00975
• 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,Followup
• Report Date: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2017
• Initial Date FDA Received: 07/31/2017
• Supplement Dates Manufacturer Received: 12/22/2017
• Supplement Dates FDA Received: 12/22/2017
• 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